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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorInova Health Care Services

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MitraClip
  • Moderate MR

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators