Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR

NCT07188233 | Recruiting

• 1 other identifier: CIP-2023-008
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

Brief Summary

Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Outcome Measures

Primary Outcomes (1)

• Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).

  Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met: 1. The patient is alive. 2. There was successful access, delivery, and retrieval of the device delivery system. 3. The first intended device was successfully deployed and correctly positioned. 4. There was freedom from emergency surgery or reintervention related to the device or access procedure.

  Periprocedural

Study Arms (1)

Single Arm

OTHER

Device: Transcatheter Mitral Valve Repair

Interventions

Transcatheter Mitral Valve Repair DEVICE

Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation

Single Arm

Eligibility Criteria

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

You may qualify if:

• Moderate to severe (3+) or severe (4+) functional mitral regurgitation
• Left ventricular ejection fraction ≥30%
• Symptomatic New York Heart Association (NYHA) Class II to IV).

You may not qualify if:

• Oxygen dependent for COPD
• Active or suspected endocarditis
• Severe symptomatic carotid stenosis
• Has undergone heart transplantation.
• Severe calcification of the mitral annulus or leaflets
• Coronary sinus anatomy that may preclude proper treatment with the device

Sponsors & Collaborators

• HVR Cardio Oy: lead

Study Sites (2)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia, Georgia

RECRUITING

Vilnius University Hospital, Santaros Klinikos, Public Institution

Vilnius, Lithuania, Lithuania

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Vinayak Bapat

  Abbott Northwestern and United Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Fleming

CONTACT

612 940 8037; tom@hvrcardio.com

Study Design

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

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: September 23, 2025
• Study Start: November 16, 2024
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

LI (1); GE (1)