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

NCT06675448 | Recruiting FDA Device

• 1 other identifier: U20-09-4258
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mitral Regurgitation; Valvular Heart Disease; Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

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

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

Interventions

MitraClip DEVICE

Participants will undergo the Mitraclip procedure according to current standards of practice

Also known as: MitraClip™ System

Mitraclip

Moderate MR OTHER

Patients who present with moderate MR (Mitral regurgitation) will serve also as an internal control against which the outcomes of Mitraclip treated patients)

Moderate MR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

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MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Valve Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Matthew Sherwood, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hassan Saeed

CONTACT

(703) 776-5716; hassan.saeed@inova.org

Mahira Awan

CONTACT

(703) 776-5716; mahira.awan@inova.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: January 28, 2021
• Primary Completion (Estimated): September 10, 2029
• Study Completion (Estimated): September 10, 2030
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)