Mitral RegurgitationPhase 1The REsOLVE TrNCT07450911
The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
A Phase 1 study testing ReValve System in people with Mitral Regurgitation, run by ReValve Solutions Inc. at 3 sites in Georgia.
Trial summary
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- ReValve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesGeorgia
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia3 sites, 3 recruiting
- Recruiting
Healthycore
Tbilisi
Site Coordinator, +995 32 243 33 43, info@hcore.ge
- Recruiting
Tbilisi Heart and Vascular Center
Tbilisi
Study Coordinator, +995 32 218 15 55, info@thvc.ge
- Recruiting
Tiblisi Heart Center
Tbilisi
Study Coordinator, +995 32 250 81 06, info@tbhc.ge
About this study
Official title: A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Conditions
- Mitral Regurgitation
- Being tested
- ReValve System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReValve SystemDevice
Mitral Valve Replacement Device
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | Not described Receives: Device: ReValve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and reduction in baseline MR.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReValve Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450911
- Sponsor's protocol ID
- CIP-003
- Acronym
- The REsOLVE Tr
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No