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

NCT ID: NCT05677568

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-24
• Study Completion Date: 2030-06-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Prospective

"Prospective" patients are identified prior to undergoing the Carillon procedure and are only enrolled after being successfully implanted with the Carillon device (prior to hospital discharge). Prospective patients will have applicable medical history and details of the Carillon implant procedure collected from medical records. After the patient is discharged, the patient's primary care specialist (cardiologist) and clinical investigation site staff will coordinate follow-up evaluations. Patients will be evaluated at one (1), six (6), twelve (12) months per standard of care and with annual contact for an additional four (4) years, for a total of five (5) years to assess long-term safety of the Carillon implant.

Carillon Mitral Contour System

Intervention Type: DEVICE

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.

Retrospective/Prospective

"Retrospective/Prospective" patients are implanted with the Carillon device and are currently being followed-up per standard of care. These patients will have applicable data collected from their medical records, including medical history, data about the Carillon procedure and follow-up visit data done since receiving the Carillon implant. They will be evaluated prospectively per standard of care follow-up through five (5) years post-implant to assess long-term safety of the Carillon implant.

Carillon Mitral Contour System

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Other Intervention Names

Cardiac Dimensions; CMCS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiac Dimensions, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Haude, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Rheinland Klinikum Neuss GmbH Lukaskrankenhaus

Locations

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

Countries

Germany

Other Identifiers

PMS-1681-01

Identifier Type: -

Identifier Source: org_study_id