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RECRUITINGPHASE1

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

NCT07450911•ReValve Solutions Inc.

Summary

An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Symptomatic MR (≥3+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.
•New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
•Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)).
•Age greater than 18 years
•Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.

Exclusion Criteria

•Untreated clinically significant coronary artery disease requiring revascularization.
•Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
•Status 1 heart transplant or prior orthotopic heart transplantation
•Cerebrovascular accident within 30 days prior to subject's consent
•Pregnant or planning pregnancy within next 12 months.
•Currently participating in an investigational drug or another device study.
•Evidence of LV or left atrium (LA) thrombus, vegetation or mass
•Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.

Locations (3)

Healthycore

Tbilisi, Georgia

Tbilisi Heart and Vascular Center

Tbilisi, Georgia

Tiblisi Heart Center

Tbilisi, Georgia

Key Dates

Start Date

January 27, 2026

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Mitral Regurgitation

Interventions

ReValve System

DEVICE

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

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RECRUITINGNA

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

NCT06282042

Acute Mitral Regurgitation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

Inclusion Criteria

Exclusion Criteria

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease

The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation

Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).