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

Launched by CARDIAC DIMENSIONS, INC. · Dec 28, 2022

Keywords

ClinConnect Summary

There are more than 22 million people worldwide with heart failure, including 5.3 million in the United States . Functional mitral regurgitation (MR), leakage of the mitral valve due to dilation of the left ventricle and annulus, occurs as a consequence of Heart Failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.

Previous studies have established that the Carillon® therapy has caused a significant reduction in functional MR. This reduction in MR results in clinically significant improvements in...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labeling
• • 2. Patients implanted with the Carillon device
• • 3. Patients must be ≥ 18 years old
• • 4. Patients require informed consent prior to inclusion in this registry
• 5. Minimum 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 diameters
• • NYHA Classification