Mitral RegurgitationPALMETTONCT07885839
The PALMETTO Study
A study testing ReValve System in people with Mitral Regurgitation, run by ReValve Solutions Inc. at 1 site in United States.
Trial summary
Prospective, single-arm, multicenter, non-randomized early feasibility study 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age greater than 18 years
- Mitral regurgitation ≥ 3+ documented by echo
- Symptomatic New York Heart Association (NYHA) Functional Class II-IVa despite optimal medical therapy for at least 30 days
Who cannot join
- Severe tricuspid valve pathology with > moderate tricuspid regurgitation.
- Greater than moderate RV dysfunction
- Significant aortic valve regurgitation greater than moderate and or stenosis greater than moderate
- Prior cardiac surgery or intervention, within 6 months that would prohibit the implant of the Palmetto Valve as determined by the screening committee
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
- Pregnant or planning pregnancy within next 12 months
Show all 9Show fewer
- Currently participating in an investigational drug or another device study
- Known hypersensitivity or contraindication to iodinated contrast media, aspirin, heparin, bivalirudin, or warfarin, where no adequate alternative therapy is available to support the required intraprocedural anticoagulation and the minimum six-month post-procedural anticoagulation regimen
- Pre-existing hemodynamically significant pericardial effusion requiring intervention at the discretion of the multidisciplinary heart team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Piedmont Hospital
Atlanta, Georgia, 30309
CV Research Project Manager, 404.605.5688, Caryn.bernstein@piedmont.org
Clinical Research Coordinator
About this study
Official title: Palmetto vAlve for Lifelong Management of patiEnts With miTral Valve regurgiTatiOn
Prospective, single-arm, multicenter, non-randomized early feasibility study
Read the detailed description
This study will evaluate the safety and performance of the ReValve System for the treatment of patients with clinically significant symptomatic primary orsecondary mitral regurgitation who are at high, but not prohibitive, surgical risk for mitral valvesurgery and, who are deemed anatomically or technically unsuitable for transcatheter edge-to-edgerepair (TEER) by the multidisciplinary heart team (MDHT).
- 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
ReValve System Mitral Valve Replacement Procedure
| Study group | Role | What they receive |
|---|---|---|
| TMVR with the ReValve System. Subjects will undergo transcatheter mitral valve replacement. | Experimental | Not described Receives: Device: ReValve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Procedural Success according to MVARC criteria
All of the following must be present:
Device Success: Absence of procedural mortality or stroke; proper placement and positioning of the device; freedom from unplanned surgical/interventional procedures related to device/access; and continued intended safety and performance.
Absence of major device or procedure related serious adverse events: Death; stroke; life-threatening bleeding (MVARC scale); major vascular complications; major cardiac structural complications; Stage 2 or 3 acute kidney injury (includes new dialysis); myocardial infarction or coronary ischemia requiring PCI or CABG; severe hypotension, heart failure, or respiratory failure requiring IV pressors, mechanical heart failure treatments, or intubation ≥48 h; or any study valve dysfunction, migration, or thrombosis requiring surgery or repeat intervention.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2031 (estimated)
- Study completionFeb 2032 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT07885839
- Sponsor's protocol ID
- CIP-001-EFS
- Acronym
- PALMETTO
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmetto vAlve for Lifelong Management of patiEnts With miTral Valve regurgiTatiOn
- ClinicalTrials.gov ID
- NCT07885839
- Acronym / sponsor ID
- PALMETTO / CIP-001-EFS
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ReValve Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single-arm, multicenter, non-randomized early feasibility study
Detailed description
This study will evaluate the safety and performance of the ReValve System for the treatment of patients with clinically significant symptomatic primary orsecondary mitral regurgitation who are at high, but not prohibitive, surgical risk for mitral valvesurgery and, who are deemed anatomically or technically unsuitable for transcatheter edge-to-edgerepair (TEER) by the multidisciplinary heart team (MDHT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMVR with the ReValve System. Subjects will undergo transcatheter mitral valve replacement. | Experimental | Device: ReValve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- Mitral regurgitation ≥ 3+ documented by echo
- Symptomatic New York Heart Association (NYHA) Functional Class II-IVa despite optimal medical therapy for at least 30 days
Key exclusion criteria (9 listed)
- Severe tricuspid valve pathology with > moderate tricuspid regurgitation.
- Greater than moderate RV dysfunction
- Significant aortic valve regurgitation greater than moderate and or stenosis greater than moderate
- Prior cardiac surgery or intervention, within 6 months that would prohibit the implant of the Palmetto Valve as determined by the screening committee
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReValve SystemReValve System Mitral Valve Replacement Procedure | Device | TMVR with the ReValve System. Subjects will undergo transcatheter mitral valve replacement. |
Primary outcome
Primary Efficacy Endpoint
Time frame: 30 Days
Procedural Success according to MVARC criteria All of the following must be present: Device Success: Absence of procedural mortality or stroke; proper placement and positioning of the device; freedom from unplanned surgical/interventional procedures related to device/access; and continued intended safety and performance. Absence of major device or procedure related serious adverse events: Death; stroke; life-threatening bleeding (MVARC scale); major vascular complications; major cardiac structural complications; Stage 2 or 3 acute kidney injury (includes new dialysis); myocardial infarction or coronary ischemia requiring PCI or CABG; severe hypotension, heart failure, or respiratory failure requiring IV pressors, mechanical heart failure treatments, or intubation ≥48 h; or any study valve dysfunction, migration, or thrombosis requiring surgery or repeat intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
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A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
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Continuous Dual Aspiration Technique With Zoom System for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReValve System in people with Mitral Regurgitation, run by ReValve Solutions Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Stewart (760-716-4015, kstewart@revalvesolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.