Actively Recruiting
A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
Led by ReValve Solutions Inc. · Updated on 2026-03-05
20
Participants Needed
3
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
CONDITIONS
Official Title
A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic mitral regurgitation of grade 3 or higher due to ischemic or non-ischemic cardiomyopathy confirmed by recent echocardiograms
- New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV
- Left ventricular ejection fraction (LVEF) of 30% or greater based on imaging in the past 90 days
- Age over 18 years
- Left ventricular end systolic dimension (LVESD) of 65 mm or less based on recent echocardiogram
You will not qualify if you...
- Untreated clinically significant coronary artery disease needing revascularization
- Need for urgent or emergency surgery or planned cardiac surgery within 12 months
- Status 1 heart transplant or prior orthotopic heart transplantation
- Stroke (cerebrovascular accident) within 30 days before consent
- Pregnant or planning pregnancy within the next 12 months
- Participation in another investigational drug or device study
- Evidence of left ventricular or left atrium thrombus, vegetation, or mass
- Known allergy or contraindication to procedural or post-procedural medications, including contrast solution, anticoagulation therapy, nickel, or titanium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Healthycore
Tbilisi, Georgia
Actively Recruiting
2
Tbilisi Heart and Vascular Center
Tbilisi, Georgia
Actively Recruiting
3
Tiblisi Heart Center
Tbilisi, Georgia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here