RecruitingNCT06675448

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


Sponsor

Inova Health Care Services

Enrollment

50 participants

Start Date

Jan 28, 2021

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a structured treatment algorithm for patients who have both heart failure and a leaky heart valve called secondary mitral regurgitation. The algorithm combines optimized medical therapy with a minimally invasive valve repair procedure (MitraClip). The goal is to determine the best sequence and combination of treatments. **You may be eligible if...** - You have heart failure with reduced ejection fraction (EF ≤ 50%) and a leaky mitral valve (≥ 2+ severity) - Your heart failure symptoms are moderate to severe (NYHA class II, III, or ambulatory IV) - Your heart team has determined that open heart surgery is not appropriate for you - Your mitral valve can likely be repaired with the MitraClip device - You have been appropriately treated for any underlying coronary artery disease **You may NOT be eligible if...** - Your mitral valve leakage is caused by a structural valve problem (as opposed to heart failure) - Your heart is too enlarged (LVESD > 70 mm) for this approach - Femoral vein access for the procedure is not feasible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMitraClip

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

OTHERModerate MR

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


Locations(1)

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

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NCT06675448


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