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Evaluating Inova's Heart Failure Treatment for Mitral Regurgitation

This study is looking at how well a specific treatment plan, called the Inova Heart Failure Treatment Algorithm (IHFTA), works for patients with heart failure and a leaky heart valve (secondary mitral regurgitation, or MR). The goal is to see if this plan helps identify which patients would benefit most from a procedure called MitraClip. The MitraClip procedure uses a device to help your heart valve close better. The study will compare patients who receive MitraClip to those with moderate MR who do not. To join, you need to be between 18 and 99 years old, have symptomatic MR (meaning you have symptoms), and your heart team must have decided that surgery on your mitral valve is not an option. The main way success will be measured is by looking at changes in your heart failure symptoms (NYHA functional class) six months after the MitraClip procedure.

Study design
This is an observational study, meaning researchers will track patients as they go through the Inova Heart Failure Treatment Algorithm. It plans to include 50 participants.
What's involved
Participants will undergo the MitraClip procedure according to current standards if identified by the algorithm. All patients passing through the algorithm will be tracked and followed.
Compensation
Not stated in the trial record.
Follow-up
Participants who undergo the MitraClip procedure will be followed for six months after the procedure to assess changes in their heart failure symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06675448

In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm

Recruiting
Not specifiedAges 18–99Observational
Inova Health Care Services
~50 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:MitraClipModerate MR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in NYHA from baseline to 6 months in patients who undergo Mitraclip
Measured over baseline to 6 months post Mitraclip procedure

Conditions

Mitral Regurgitation
Valvular Heart Disease
Heart Failure

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Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Matthew Sherwood, MD · PRINCIPAL_INVESTIGATOR · Inova Health Care Services

Who to contact

Hassan Saeed
[email protected]
(703) 776-5716
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in NYHA from baseline to 6 months in patients who undergo Mitraclipbaseline to 6 months post Mitraclip procedure

    There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).