MedTrace Logo

The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation

NCT05677568 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2023-03-14

No results posted yet for this study

Summary

This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon® Mitral Contour System® (CMCS) in a commercial (post market) setting.

Conditions

  • Functional Mitral Regurgitation
  • Mitral Regurgitation

Interventions

DEVICE

Carillon Mitral Contour System

The Cardiac Dimensions Carillon Mitral Contour System (CMCS) is a medical device and consists of the following components: 1. A proprietary implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV) 2. A catheter-based delivery system which consists of a curved CMCS delivery catheter (3.2mm outer diameter) and a handle assembly 3. A sizing catheter to enable the physician to estimate the overall CS/GCV dimensions so that an appropriately sized implant may be selected The implant is attached to the handle assembly and is delivered through the CMCS delivery catheter to the coronary vein along the posterolateral aspect of the mitral annulus. The implant is designed to re-shape the mitral annulus to reduce annular dilation and mitral regurgitation.

Sponsors & Collaborators

  • Cardiac Dimensions, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Haude, Prof. Dr. · Rheinland Klinikum Neuss GmbH Lukaskrankenhaus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-24
Primary Completion
2025-06-30
Completion
2030-06-30
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

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 NCT05677568 on ClinicalTrials.gov