The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carillon Mitral Contour System.
- Who it may be relevant to
- Registry conditions: Functional Mitral Regurgitation, Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 se
Primary outcome measures
- Death [Time frame: 6 months]
- Death [Time frame: 12 months]
- Death [Time frame: 24 months]
- Death [Time frame: 3 years]
- Death [Time frame: 4 years]
- Death [Time frame: 5 years]
- Serious adverse events [Time frame: 6 months]
- Serious adverse events [Time frame: 12 months]
- Change in New York Heart Association (NYHA) classification [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Rate of Heart Failure Hospitalizations [Time frame: 6 months]
Secondary outcome measures (12)
- Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL) [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%) [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR Severity via Quantitative MR Variable: effective regurgitant orifice area (cm2 EROA) [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax. [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow. [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Atrial Area [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Atrial Diameter [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Atrial Volume Index [Time frame: 6, 12, and 24 months, and 3, 4, and 5 years]
- Change in Left Ventricular End Systolic Volume (LVESV) [Time frame: 6,12, and 24 months, and 3, 4, and 5 years]
- Change in Left Ventricular End Diastolic Volume (LVEDV) [Time frame: 6,12, and 24 months, and 3, 4, and 5 years]
- Change in Left Ventricular End Systolic Diameter (LVESD) [Time frame: 6,12, and 24 months, and 3, 4, and 5 years]
Eligibility criteria
Inclusion criteria
- Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labeling
- Patients implanted with the Carillon device
- Patients must be ≥ 18 years old
- Patients require informed consent prior to inclusion in this registry
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 19 centers
- Universitätsklinikum Aachen — Aachen
- St. Marien Krankenhaus- Ahaus Vreden — Ahaus
- Sana Klinikum Lichtenberg — Berlin
- Klinikum Links der Weser — Bremen
- Kardiovaskular Zentrum Darmstadt — Darmstadt
- Herzzentrum Dresden — Dresden
- Cardiovascular Center Frankfurt — Frankfurt
- Universtitätsklinikum Frankfurt — Frankfurt
- … and 11 more centers
Identifiers
NCT: NCT05677568 · PMS-1681-01