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The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Sponsor: Cardiac Dimensions, Inc.
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
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