In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Inova Health Care Services
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in NYHA from baseline to 6 months in patients who undergo Mitraclip
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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
Investigators
Eligibility Criteria
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 (if a secondary jet exists, it must be considered clinically insignificant).
- •Transseptal catheterization and femoral vein access is feasible per the MitraClip implanting investigator.
- •Age 18 y or older
- •Subject or guardian agrees to all provisions of the protocol
Exclusion Criteria
- •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
- •Cerebrovascular accident within prior 30 d
- •Severe symptomatic carotid stenosis (N70% by ultrasound)
- •Carotid surgery or stenting within prior 30 d
- •ACC/AHA stage D HF
- •Presence of any of the following:
- •Estimated PASP N70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the PVR to b3 Wood units or between 3 and 4.5 Wood units with v wave less than twice the mean of the PCWP
Outcomes
Primary Outcomes
Change in NYHA from baseline to 6 months in patients who undergo Mitraclip
Time Frame: baseline to 6 months post Mitraclip procedure
There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).