NCT06675448

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Mitral Regurgitation
• Valvular Heart Disease
• Heart Failure

Interventions

Type	Name	Description
DEVICE	MitraClip	Participants will undergo the Mitraclip procedure according to current standards of practice
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)

Timeline

• Start date: 2021-01-28
• Primary completion: 2029-09-10
• Completion: 2030-09-10
• First posted: 2024-11-05
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study