Replacement of the Native Mitral Valve Using the ReValve System

NCT07601269 | Recruiting Early Phase 1

• 1 other identifier: CIP-002 Brazil
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to collect preliminary chronic information on performance and safety of the ReValve System.

Conditions

Mitral Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Technical Success

  The Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and withdrawal of the delivery system

  Procedure

Study Arms (1)

Single Arm Study

EXPERIMENTAL

Device: ReValve System

Device: ReValve System

Interventions

ReValve System DEVICE

Mitral Valve Replacement Device

Single Arm Study

Eligibility Criteria

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

You may qualify if:

• Symptomatic functional and/or degenerative MR (≥2+) 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 CT.
• 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 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 (2)

Institute Dante Pazzanese of Cardiology - IDPC

São Paulo, São Paulo, SP, 04012-909, Brazil

RECRUITING

The Heart Institute - INCOR

São Paulo, São Paulo, SP, 05403-900, Brazil

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: April 26, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)