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

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT06675448
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MitraClip — DEVICE
    Participants will undergo the Mitraclip procedure according to current standards of practice
  • 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)

Study Details

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

Key Dates

Start date
Jan 28, 2021
Status verified
Dec 2025
Primary completion
Sep 10, 2029
Completion
Sep 10, 2030

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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

Primary Outcome Measure

Change in NYHA from baseline to 6 months in patients who undergo Mitraclip [ Time Frame: baseline to 6 months post Mitraclip procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax Medical CampusFalls ChurchVirginia22042
Hassan Saeed
Mahira Awan
[email protected]

Find similar trials in Falls Church, VA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Inova Fairfax Medical Campus· Falls Church, VA

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