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

NCT07450911 | Recruiting Phase 1 DMC

• 1 other identifier: CIP-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Technical Success

  Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and reduction in baseline MR.

  Procedure

Study Arms (1)

Single Arm Study

EXPERIMENTAL

Device: ReValve System

Interventions

ReValve System DEVICE

Mitral Valve Replacement Device

Single Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ReValve Solutions Inc.: lead

Study Sites (3)

Healthycore

Tbilisi, Georgia

RECRUITING

Tbilisi Heart and Vascular Center

Tbilisi, Georgia

RECRUITING

Tiblisi Heart Center

Tbilisi, Georgia

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 5, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (3)