NCT05677568

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Cardiac Dimensions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 exercise tolerance, quality of life, and thus overall function in a symptomatic heart failure population. To supplement the findings from these previous studies, Cardiac Dimensions is conducting this post-market registry of the Carillon® Mitral Contour System® (CMCS) in patients with functional mitral regurgitation. This registry is a retrospective and prospective, multi-center, clinical registry designed to further characterize the acute and long-term safety and performance profile of the CMCS. Up to 250 implanted patients will be enrolled at up to 40 centers located in the European Union and countries that recognize the CE-mark as a valid marketing authorization. Patients enrolled in the registry have received the Carillon implant and will be assessed to document the long-term safety and performance of the device. These patients will be followed according to routine standard of care post procedure follow up assessments.

Conditions

• Functional Mitral Regurgitation
• Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-24
• Primary completion: 2025-06-30
• Completion: 2030-06-30
• First posted: 2023-01-10
• Last updated: 2023-03-14

Locations

19 sites across 1 country: Germany

Regulatory

• FDA-regulated device study