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ENROLLING BY INVITATION
NCT05677568

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

Sponsor: Cardiac Dimensions, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2017-06-24

Completion Date

2030-06-30

Last Updated

2023-03-14

Healthy Volunteers

No

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.

Locations (19)

Universitätsklinikum Aachen

Aachen, Germany

St. Marien Krankenhaus- Ahaus Vreden

Ahaus, Germany

Sana Klinikum Lichtenberg

Berlin, Germany

Klinikum Links der Weser

Bremen, Germany

Kardiovaskular Zentrum Darmstadt

Darmstadt, Germany

Herzzentrum Dresden

Dresden, Germany

Cardiovascular Center Frankfurt

Frankfurt, Germany

Universtitätsklinikum Frankfurt

Frankfurt, Germany

Hostpital zum Heiligen Geist

Fritzlar, Germany

Asklepios Klinik Altona

Hamburg, Germany

Kath. Marienkrankenhaus GmbH- Hamburg

Hamburg, Germany

Krankenhaus Agatharied GmbH

Hausham, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Universitätsmedizin Mainz

Mainz, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Rheinland Klinikum Neuss GmbH- Lukaskrankenhaus

Neuss, Germany

Universitätsklinikum Ulm

Ulm, Germany

Josefs Hospital Wiesbaden

Wiesbaden, Germany