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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ReValve System as a treatment option for people with clinically significant mitral regurgitation who are suitable candidates for mitral valve surgery. This clinical study focuses on replacing the native mitral valve using this device, aiming to assess its technical success during the procedure. The study is in its early phase and sponsored by ReValve Solutions Inc. Participants will receive the ReValve System, a device designed to replace the mitral valve. This is a single-arm study where all participants undergo the investigational procedure with the device. There are no comparison groups or placebos involved. During the study, participants will be monitored for the technical success of the procedure. Assessments may include heart function tests such as echocardiograms and other cardiac imaging to evaluate valve performance. The study will continue until January 2028, with follow-up planned to understand the outcomes of the valve replacement.
CONDITIONS
Brief 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 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 higher
- Age above 18 years
- Left Ventricular End Systolic Dimension (LVESD) of 65 mm or less based on recent echocardiogram
You will not qualify if you...
- Untreated significant coronary artery disease needing revascularization
- Need for urgent or planned cardiac surgery within 12 months
- Status 1 heart transplant or prior orthotopic heart transplantation
- Stroke within 30 days prior to consent
- Pregnant or planning pregnancy within 12 months
- Participation in another investigational drug or device study
- Presence of thrombus, vegetation, or mass in left ventricle or left atrium
- Known allergy or contraindication to procedural or post-procedure medications or materials like nickel or titanium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo replacement of the native mitral valve using the ReValve System device.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored after the valve replacement procedure to assess recovery and device performance.
Approximately 6 post-operative visits (in-person)
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
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