In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
Inova Health Care Services
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
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 coho…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
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)
Location
- Inova Fairfax Medical CampusFalls Church, Virginia