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

December 1, 2025 updated by: Inova Health Care Services

The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR

Aim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients passing through the IHFTA will be tracked and followed w.r.t. their final therapies. Monthly meetings will occur with the IHFTA research team to assess and discuss any challenges in implementing the protocol. Impediments will be identified, and strategies put forth to address them. To examine whether the Inova IHFTA identifies the patient most likely to benefit from Mitraclip, the baseline clinical and echocardiographic characteristics of patients treated with Mitraclip within the IHFTA (who would have met the criteria for COAPT study) will be compared to those of the treated cohort in the COAPT trial using t-tests and Chi-squared tests

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Medical Campus
        • Contact:
          • Hassan Saeed
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Moderate MR
Patients who present with moderate MR and remain in this state will be re-evaluated at 6 months by a phone call and EMR review for ConComitant Cardiac Medication Review, NYHA Class and Adverse Event Evaluation. At 12 months a follow-up evaluation that will include a review of medications, NYHA class, KCCQ, 6MWT, BNP, Adverse Event review and TTE.
Other: Moderate MR
Patients who present with moderate MR (Mitral regurgitation) will serve also as an internal control against which the outcomes of Mitraclip treated patients)
Mitraclip
For patient who undergo Mitraclip, the safety and effectiveness of the procedure will be evaluated and all peri-procedural complications recorded using the same definitions for procedural success and complications used in the COAPT trial
Device: MitraClip
Participants will undergo the Mitraclip procedure according to current standards of practice
Other Names:
  • MitraClip™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NYHA from baseline to 6 months in patients who undergo Mitraclip
Time Frame: baseline 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).
baseline to 6 months post Mitraclip procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Matthew Sherwood, MD, Inova Health Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Estimated)

September 10, 2029

Study Completion (Estimated)

September 10, 2030

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U20-09-4258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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