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Enrolling By Invitation
NCT05677568
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Conditions: Functional Mitral Regurgitation, Mitral Regurgitation
Sex: All
Ages: 18 Years – N/A
Enrollment: 150
Sponsor: Cardiac Dimensions, Inc.
Location: Germany
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.
Eligibility Criteria
Inclusion Criteria:Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labelingPatients implanted with the Carillon devicePatients must be ≥ 18 years oldPatients require informed consent prior to inclusion in this registryMinimum baseline data, as described in CINCH Protocol, including:Hemodynamic measures (by echocardiography)Baseline must include the following measurements: MR grade, LVEF (%), LVEDD, LAD, and AP & ML diametersNYHA Classification
Source: ClinicalTrials.gov (NCT05677568). StuddyBuddy aggregates publicly available trial information.