Search Results Within Category "Heart & Vascular"

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

Search all categories
7results

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

clinicaltrials@northshore.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT03142152
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Diagnosis of ischemic or non-ischemic cardiomyopathy
• Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study.
• NYHA Class II, III, or IV
• Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
• Left Ventricular Ejection Fraction ≤ 50%
• LVEDD ≥ 57 mm and LVESD ≤ 75 mm
• Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
• Guideline directed heart failure medication regimen.
Exclusion Criteria:

• Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)
• Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
• Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture), as assessed by the Imaging Core Laboratory
• Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
• Severe mitral annular calcification
• Severe aortic stenosis
• Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
• Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study * An entire list of eligibility is available in the clinical investigational plan
DEVICE: Carillon Mitral Contour System, OTHER: Guideline Directed Heart Failure Medication
Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases, Heart Valve Diseases
Functional Mitral Regurgitation, Percutaneous Mitral Valve Repair, Percutaneous Mitral Valve Annuloplasty, Coronary Sinus Annuloplasty, Secondary Mitral Regurgitation, Functional MR, FMR
I'm interested

Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (PROTECT IV)

clinicaltrials@northshore.org

ALL
18 years to 90 years old
NA
This study is NOT accepting healthy volunteers
NCT04763200
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Age ≥18 years and ≤90 years
• Clinical presentation and baseline left ventricular function are as follows: Either 2A or 2B must be present A. Subject has CCS or NSTEMI with an LVEF ≤40% NOTE: The LVEF must be quantitatively measured as ≤40% by echo within 30 days assuming no change in clinical condition. If multiple echos have been performed within 30-days, the most recent test must be used to qualify the patient. NOTE: Subject qualifies if the quantitative site read LVEF is ≤30%; if the quantitative site read is \>30% - ≤40% the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment (Core Lab will provide \<48-hour turnaround). Similarly, if the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment. OR B. Subject has STEMI ≥24 hours and \<30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment.
• Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient
• Complex PCI will be performed: Either 4A or 4B must be met A. One of the following must be present: i. Triple vessel disease is present (visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89)\] is present in all 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) with PCI planned in ≥2 of these vessels in the proximal or mid LAD, proximal or mid-LCX or proximal, mid- or distal RCA \[i.e., not a branch vessel\]) OR ii. Left main distal bifurcation or trifurcation disease (visually-assessed DS ≥50% \[or DS ≥30% if non-invasive evidence of ischemia in both the anterior and posterolateral distributions or left main IVUS MLA ≤6.0 mm2 or FFR ≤0.80 or iFR ≤0.89\] is present) with planned intervention of the left main plus at least 2 branch vessels (i.e., the ostial LAD, ostial LCX or ostial ramus) OR iii. Left main equivalent disease with both ostial LAD and ostial LCX having visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89\] and requiring intervention in both branches OR iv. Intervention of the last remaining vessel (native coronary artery or bypass graft) OR B. Multivessel disease is present (visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive or invasive evidence of ischemia is present\] in ≥2 of the 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) and PCI is planned of at least 2 separate complex lesions in main vessels or branch vessels each having one or more of the following characteristics: i. Long lesion (≥28 mm visually assessed) requiring ≥30 mm stent length (single or multiple) ii. Severe angiographic calcification (see Protocol definition) or requiring atheroablation iii. Any left main morphology not in Criterion A requiring intervention (e.g., isolated ostial or mid-shaft left main lesion or distal left main bifurcation lesion with a planned single provisional stent technique) iv. Non-left main bifurcation lesion requiring intervention in both the main branch and side branch v. CTO (TIMI 0 Flow) vi. Giant thrombus (length ≥3x vessel diameter) vii. SVG (other than focal (\<5 mm) disease of the proximal or distal anastomosis or in-stent restenosis) NOTES:
• The multiple lesions can be in the same vessel if separated by ≥10 mm - however, each separate lesion has to have one or more of the above characteristics
• PCI may be performed on additional non-qualifying lesions (i.e., without 1 or more of the above high-risk characteristics) as long as there are at least two lesions also undergoing PCI with each having 1 or more of the above characteristics)
• There are 2 exceptions to the rule that each separate lesion must have one or more of the above characteristics (as in Inclusion Criterion 4B above): The subject may qualify if undergoing complex PCI of a single lesion that has 2 or more of the above complex characteristics (as in Inclusion Criterion 4B above) if also: i. There is a CTO of a proximal or mid-LAD, proximal or mid-LCX or proximal, mid- or distal RCA (i.e., not a branch vessel) that will not be treated OR ii. The subject qualifies with recent STEMI with an LVEF ≤30% and the complex PCI is planned in a non-infarct vessel (i.e., a complex PCI in the infarct vessel does not qualify)
• Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent
Exclusion Criteria:
Subjects must not meet ANY of the following Exclusion Criteria to participate in the Trial:
• STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
• Cardiogenic shock (SBP \<80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
• Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \>24 hours with full neurologic recovery)
• Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable
• Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter \<5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can't be adequately treated (e.g., with intravascular lithotripsy) NOTES:
• Computed tomography (CT), magnetic resonance angiography (MRA) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 90 days prior to randomization. It is recommended that this evaluation be performed prior to the index procedure. Absent a qualifying pre-procedure imaging study, contrast angiography of the potential Impella access vessel(s) must be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies. Of note, if pre-procedure imaging was performed and after this test but before randomization there was a worsening in PVD symptoms, repeat imaging must be performed prior to randomization.
• If iliofemoral peripheral vascular disease is present precluding Impella use that can be adequately treated with angioplasty, atherectomy or lithotripsy (without a stent), the subject can be enrolled if such treatment is undertaken and is successful and uncomplicated - randomization must not be performed until such successful and uncomplicated treatment
• Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments
• Vascular access for Impella is required in any location other than the left or right common femoral artery (i.e., axillary access, transcaval access, etc., for Impella access are not permitted)
• Known left ventricular thrombus
• Incessant ventricular arrhythmias that would likely preclude stable Impella positioning
• Severe aortic stenosis or severe aortic insufficiency
• Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic surgical valve or balloon expandable TAVR implanted \>24 hours pre-procedure is acceptable)
• Prior CABG within three (3) months or successful prior PCI of at least one (1) attempted lesion within 12 months (including during the index hospitalization prior to randomization), that has not experienced stent thrombosis or restenosis during that 12-month period; the one (1) exception is that patients may be enrolled if a primary PCI for STEMI was performed during the index hospitalization without MCS and that was ≥24 hours and \<30 days prior to randomization. NOTE: Successful PCI for this exclusion criterion is defined as a visually-assessed angiographic DS ≤50% in at least one (1) attempted lesion.
• Prior placement of IABP, Impella or any other MCS device for any reason during the index admission, prior to randomization
• Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization) \>70 mm Hg unless active vasodilator therapy in the Cath Lab is able to reduce the pulmonary vascular resistance (PVR) to \<3 Wood Units or between 3 and 4.5 Wood Units with v-wave less than twice the mean of the pulmonary capillary wedge pressure
• Symptoms or signs of severe RV dysfunction, such as anasarca (NOTE: Leg edema alone does not necessarily indicate severe RV dysfunction if the investigator believes it is due to LV dysfunction)
• Severe tricuspid insufficiency
• Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions
• On dialysis
• Prior stroke with any permanent neurologic deficit within the previous three (3) months, or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
• Taking a chronic oral anticoagulant that cannot be safely discontinued for at least 72-hours before and 72-hours after the index procedure (if a vitamin K antagonist) or that cannot be safely discontinued for at least 48 hours before and 48 hours after the index procedure (for a direct acting oral anticoagulant)
• Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents
• Pregnant or child-bearing potential unless negative pregnancy test within 1 week
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
• Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
• Any non-cardiac condition with life expectancy \<3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.)
• Subject is currently hospitalized for definite or suspected COVID-19
• Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
• Subject is asymptomatic (never ill) and COVID-19 PCR/antigen test is positive within the prior four (4) weeks unless a) subject remains asymptomatic for ≥2 weeks after the last positive test or b) the positive test occurred within six (6) months after the subject received a COVID vaccine
• Subject belongs to a vulnerable population (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
DEVICE: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, DEVICE: IABP Intra-aortic balloon pump
Left Ventricular Dysfunction, Coronary Artery Disease
Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction
I'm interested

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation (LIBREXIA-AF)

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT05757869
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Minimum age of 18 years * Medically stable and appropriate for chronic antithrombotic treatment * Atrial fibrillation eligible to receive anticoagulation * Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure
Exclusion Criteria:
* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study * Any condition other than AF that requires chronic anticoagulation
DRUG: Milvexian, DRUG: Apixaban, DRUG: Placebo, DRUG: Apixaban Placebo
Atrial Fibrillation
I'm interested

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)

clinicaltrials@northshore.org

ALL
22 years to 85 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT05836987
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• 22-85 years of age.
• English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
• History of non-permanent atrial fibrillation.
• CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%.
• The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
• Willing and able to comply with the protocol, including: * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan * Be willing to wear the smart watch for the suggested minimum of 14 hours a day * Expected to be within cellular service range at least 80% of the time
• Willing and able to discontinue DOAC
• The participant is willing and able to provide informed consent.
Exclusion Criteria:

• Valvular or permanent atrial fibrillation.
• Current treatment with warfarin and unwilling or unable to take a DOAC.
• The participant is a woman who is pregnant or nursing.
• The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
• Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.
• Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
• Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI.
• Ablation for AF within the last 2 months.
• Prior or anticipated left atrial appendage occlusion or ligation.
• Mechanical prosthetic valve(s) or severe valve disease.
• Hypertrophic cardiomyopathy.
• Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).
• Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion.
• The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.
• The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
• The participant has a tremor on their ipsilateral side that the AFSW may be worn.
• Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
• Known hypersensitivity or contraindication to direct oral anticoagulants.
• Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
• Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
• \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.
• History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).
• Stage 4 or 5 chronic kidney disease.
• Conditions associated with an increased risk of bleeding: * Major surgery in the previous month * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks. * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days * Hemorrhagic disorder or bleeding diathesis * Need for anticoagulant treatment for disorders other than AF * Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)
DEVICE: AFSW Guided DOAC, DRUG: Continuous DOAC therapy
Atrial Fibrillation
Atrial Fibrillation, Anticoagulation, AF-sensing Smart Watch, Ischemic Stroke, Systemic Embolism
I'm interested

SYMPHONY-PE Study for Treatment of Pulmonary Embolism

clinicaltrials@northshore.org

ALL
18 years to 80 years old
NA
This study is NOT accepting healthy volunteers
NCT06062329
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• CTA evidence of acute PE within ≤14 days
• Clinical signs and symptoms consistent with acute PE.
• Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio \>0.9 (based on Investigator's assessment of RV/LV ratio)
• Stable heart rate \<130 BPM prior to procedure
• Subject is between 18 and 80 years of age
• Subject is willing to sign an IRB-approved informed consent form
• Subject is willing and able to comply with protocol follow-up
Exclusion Criteria:

• Thrombolytic use within 14 days of baseline CTA
• International Normalized Ratio (INR) \>3
• Platelets \<100,000/µL
• Kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dL or GFR \<45 mL/min
• Hematocrit \<28% or hemoglobin \<9 g/dL
• Systolic BP \<90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission
• Experienced cardiac arrest
• Has left bundle branch block
• Known bleeding diathesis or coagulation disorder
• Presence of intracardiac lead in the right ventricle or right atrium
• Presence of intracardiac thrombus
• Major trauma within the past 14 days
• Cardiovascular or pulmonary surgery within last 7 days
• Known serious, uncontrolled sensitivity to radiographic agents
• Contraindication to anticoagulants, i.e., heparin or alternative
• Patient on extracorporeal membrane oxygenation (ECMO)
• Cancer requiring active chemotherapy
• Heparin-induced thrombocytopenia (HIT)
• Pulmonary hypertension with peak pulmonary artery pressure \>70 mmHg by right heart catheterization.
• History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30%
• Life expectancy \<90 days as determined by investigator
• Pregnant or nursing
• COVID-19 positive at hospital admission
• Current participation in another investigational study
• Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).
DEVICE: Symphony Thrombectomy System
Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus, Embolism, Embolism, Cardiovascular Diseases, Vascular Diseases
Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction
I'm interested

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

clinicaltrials@northshore.org

ALL
18 years and over
PHASE3
This study is NOT accepting healthy volunteers
NCT03907046
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Age at least 18 years * Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI * Can be randomized within 14-180 days after ICH onset * Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF * Provision of signed and dated informed consent form by patient or legally authorized representative * For females of reproductive potential: use of highly effective contraception
Exclusion Criteria:
* Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor * History of earlier ICH within 12 months preceding index event * Active infective endocarditis * Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent). * Previous or planned left atrial appendage closure * Clinically significant bleeding diathesis * Serum creatinine ≥2.5 mg/dL * Active hepatitis or hepatic insufficiency with Child-Pugh score B or C * Anemia (hemoglobin \<8 g/dL) or thrombocytopenia (\<100 x 10\^9/L) that is chronic in the judgment of the investigator * Pregnant or breastfeeding * Known allergy to aspirin or apixaban * Concomitant participation in a competing trial * Considered by the investigator to have a condition that precludes safe or active participation in the trial * Persistent, uncontrolled systolic blood pressure (≥180 mm Hg) * ICH caused by an arteriovenous malformation (AVM) that has not yet been secured
DRUG: Apixaban, DRUG: Aspirin
Intracerebral Hemorrhage, Atrial Fibrillation
I'm interested

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)

clinicaltrials@northshore.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT05686317
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:
* Symptomatic heart failure * A primary diagnosis of HFmrEF or HFpEF (LVEF \> 40%), and * NYHA class II to ambulatory NYHA class IV (IVa), and * Documentation of at least one of the following from the date of initial informed consent: * ≥ 1 prior HF hospitalization(s) requiring IV HF therapy in the prior 12 months; AND/OR * EITHER BNP value \> 35 pg/ml or \> 125 pg/ml in permanent or long-term persistent atrial fibrillation; OR * NT-proBNP \> 125 pg /ml or \> 375 pg /ml in permanent or long-term persistent atrial fibrillation * There is objective evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core lab as: o As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at ≥ 20 Watts exercise (PCWP ≥ 20W) is elevated to ≥ 25 mmHg and exceeds \[the corresponding\] right atrial pressure (RAP) by ≥ 8 mmHg * In the judgment of the treating physician and the Central Screening Committee the patient is on GDMT for HFpEF/HFmrEF for \>30 days prior to screening and baseline assessments, that is expected to be maintained without change for 6 months. Key
Exclusion Criteria:
* Severe heart failure defined as one or more of the below: * ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF * If Body Mass Index (BMI) \< 30, cardiac index \< 2.0 L/min/m2 * If BMI ≥ 30, cardiac index \< 1.8 L/min/m2 * Inotropic infusion (continuous or intermittent) within the past 6 months * Patient is on the cardiac transplant waiting list * Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to \> 40% * Valve disease: * Degenerative mitral regurgitation \> moderate * Functional or secondary mitral valve regurgitation defined as grade \> moderate * Mitral stenosis \> mild * Primary or secondary tricuspid valve regurgitation defined as grade \> moderate * Aortic valve disease defined as aortic regurgitation grade \> moderate or aortic stenosis \> moderate * More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters: * Tricuspid annular plane systolic excursion (TAPSE) \<1.4 cm, or * RV size ≥ LV size * Right ventricular ejection fraction (RVEF) \< 35%; OR * Imaging or clinical evidence of congestive hepatopathy * Mean right atrial pressure (mRAP) \> 15 mmHg at rest * Pulmonary vascular resistance (PVR) ≥ 5.0 WU * BMI ≥ 45 * Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular cardiovascular procedure within past 3 months or current indication for coronary revascularization * Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months * Renal insufficiency as determined by creatinine (sCr) level \> 2.5 mg/dL or estimated glomerular filtration rate (eGFR) \< 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis * Performance of the six-minute walk test (6MWT) with a distance \< 50m OR \> 450m * Active endocarditis or infection requiring intravenous antibiotics within 3 months
DEVICE: Edwards APTURE transcatheter shunt system, DIAGNOSTIC_TEST: Sham procedure
Heart Failure
I'm interested