NCT07450911RecruitingPhase 1
A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
ReValve Solutions Inc.3 sites in 1 country20 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Technical Success
Study Overview
Brief Summary
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Single Arm Study
Experimental
Intervention: ReValve System (Device)
Outcomes
Primary Outcomes
Technical Success
Time Frame: Procedure
Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and reduction in baseline MR.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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