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

NCT07188233 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-23

No results posted yet for this study

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)

Interventions

DEVICE

Transcatheter Mitral Valve Repair

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

Sponsors & Collaborators

  • HVR Cardio Oy

    lead INDUSTRY

Principal Investigators

  • Vinayak Bapat · Abbott Northwestern and United Hospitals

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-16
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Georgia
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188233 on ClinicalTrials.gov