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New algorithm aims to match heart failure patients with the right valve repair

NCT ID NCT06675448

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tests a hospital-wide treatment guide for people with heart failure and a leaky mitral valve (secondary mitral regurgitation). The goal is to see if the guide helps doctors identify which patients will benefit most from a minimally invasive valve repair procedure called Mitraclip. About 50 adults with moderate to severe symptoms will take part, and the main measure is improvement in daily activity levels after 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

33 people

The number who actually took part.

Started

Jan 2021

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population for this study include adult patients \> 18 years of age who have symptomatic (NYHA class II-IVa) HFreF due to ischemic or idiopathic dilated cardiomyopathy (LV ejection fraction ≤ 50%), moderate (2+) to severe (4+) secondary MR and either at least 1 HF hospitalization within the prior 12 months or an elevated brain natriuretic peptide (BNP≥300) or N-terminal pro b-type natriuretic peptide (NT-proBNP ≥ 1500) and have been determined by the site's local heart team as not being appropriate for MV surgery. This study population is similar to patients enrolled in COAPT, but includes patients who present with moderate 2+ MR and others who may end up needing only optimal GDMT and/or CRT or Cardiomems.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic MR (≥2+) due to cardiomyopathy of either ischemic or nonischemic etiology * Subject has been adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, MR, and HF. * NYHA functional class II, III, or ambulatory IV * Local heart team has determined that MV surgery will not be offered as a treatment option even if the subject is randomized to the Control group. * LVEF ≤50%. * LVESD ≤70 mm * The primary regurgitant jet , in the opinion of the MitraClip implanting investigator, can be successfully treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant). * Transseptal catheterization and femoral vein access is feasible per the MitraClip implanting investigator. * Age 18 y or older * Subject or guardian agrees to all provisions of the protocol * NT-proBNP≥ 1500ng/ml or BNP≥ 300ng/ml Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization * CABG, PCI, or TAVR within the prior 30 d * Aortic or tricuspid valve disease requiring surgery or transcatheter intervention * COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use * Cerebrovascular accident within prior 30 d * Severe symptomatic carotid stenosis (N70% by ultrasound) * Carotid surgery or stenting within prior 30 d * ACC/AHA stage D HF * Presence of any of the following: * Estimated PASP N70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the PVR to b3 Wood units or between 3 and 4.5 Wood units with v wave less than twice the mean of the PCWP * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than dilated cardiomyopathy of either ischemic or nonischemic etiology * Infiltrative cardiomyopathies (eg, amyloidosis, hemochromatosis, sarcoidosis) * Hemodynamic instability requiring inotropic support or mechanical heart assistance * Physical evidence of right-sided congestive HF with echocardiographic evidence of moderate or severe right ventricular dysfunction * Implant of CRT or CRT-D within the last 30 d * Mitral valve orifice area \<4.0 cm2 by site-assessed TTE * Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets, or sufficient reduction in MR by the MitraClip * Hemodynamic instability defined as persistent systolic pressure \<90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 m * Life expectancy \<12 m due to noncardiac conditions * Investigators opinion a condition that could limit the subject's participation * Status 1 heart transplant or prior orthotopic heart transplantation * Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (ie, noncompliant, perforated) * Active infections requiring current antibiotic therapy * TEE is contraindicated or high risk * Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically * Pregnant or planning pregnancy within next 12m * Currently participating in an investigational drug or another device study that has not reached its primary end point * Subject belongs to a vulnerable population or has any disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.