In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: A… (NCT06675448) | Clinical Trial Compass
RecruitingNot Applicable
In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
United States50 participantsStarted 2021-01-28
Plain-language 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
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* NT-proBNP≥ 1500ng/ml or BNP≥ 300ng/ml
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 echoca…
What they're measuring
1
Change in NYHA from baseline to 6 months in patients who undergo Mitraclip
Timeframe: baseline to 6 months post Mitraclip procedure