The PALMETTO Study

NCT07885839 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CIP-001-EFS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, single-arm, multicenter, non-randomized early feasibility study

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Days

Study Arms (1)

TMVR with the ReValve System. Subjects will undergo transcatheter mitral valve replacement.

EXPERIMENTAL

Device: ReValve System

Interventions

ReValve System DEVICE

ReValve System Mitral Valve Replacement Procedure

TMVR with the ReValve System. Subjects will undergo transcatheter mitral valve replacement.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ReValve Solutions Inc.: lead

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Kevin Stewart

CONTACT

760-716-4015; kstewart@revalvesolutions.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): February 1, 2032
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)