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

March 3, 2026 updated by: ReValve Solutions Inc.
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Tbilisi Heart and Vascular Center
        • Contact:
          • Study Coordinator
          • Phone Number: +995 32 218 15 55
          • Email: info@thvc.ge
      • Tbilisi, Georgia
        • Recruiting
        • Healthycore
        • Contact:
          • Site Coordinator
          • Phone Number: +995 32 243 33 43
          • Email: info@hcore.ge
      • Tbilisi, Georgia
        • Recruiting
        • Tiblisi Heart Center
        • Contact:
          • Study Coordinator
          • Phone Number: +995 32 250 81 06
          • Email: info@tbhc.ge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm Study
Device: ReValve System
Mitral Valve Replacement Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: Procedure
Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and reduction in baseline MR.
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReValve Solutions Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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