The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
- Conditions
- Functional Mitral RegurgitationMitral Regurgitation
- Interventions
- Device: Carillon Mitral Contour System
- Registration Number
- NCT05677568
- Lead Sponsor
- Cardiac Dimensions, Inc.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 250
-
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retrospective/Prospective Carillon Mitral Contour System "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. Prospective Carillon Mitral Contour System "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.
- Primary Outcome Measures
Name Time Method Death 5 years All cause mortality including cardiovascular and non-cardiovascular death
Change in New York Heart Association (NYHA) classification 6, 12, and 24 months, and 3, 4, and 5 years Change in New York Heart Association (NYHA) Functional Classification at 6, 12, and 24 months, and 3, 4, and 5 years
Rate of Heart Failure Hospitalizations 5 years Rate of hospitalization for heart failure
Serious adverse events 12 months Number of procedure related or device related serious adverse events
- Secondary Outcome Measures
Name Time Method Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%) 6, 12, and 24 months, and 3, 4, and 5 years change in MR severity based on regurgitant fraction (%) as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width 6, 12, and 24 months, and 3, 4, and 5 years Change in vena contract width MR severity as assessed by echocardiography in hospital 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Change of MR Severity via Quantitative MR Variable: effective regurgitant orifice area (cm2 EROA) 6, 12, and 24 months, and 3, 4, and 5 years change in MR severity based on effective regurgitant orifice area (cm2, EROA) as assessed by by Proximal Isovelocity Surface Area (PISA) via echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax. 6, 12, and 24 months, and 3, 4, and 5 years Change in MV EVmax MR severity as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Change in Left Atrial Area 6, 12, and 24 months, and 3, 4, and 5 years Change in Left Atrial Area as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in Left Atrial Volume Index 6, 12, and 24 months, and 3, 4, and 5 years Change in Left Atrial Volume as assessed by echocardiography Index at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in Quality-of-Life Overall Score 6,12, and 24 months, and 3, 4, and 5 years Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6,12, and 24 months, and 3, 4, and 5 years over baseline
Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL) 6, 12, and 24 months, and 3, 4, and 5 years change in MR severity based in regurgitant volume as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Change in Left Ventricular End Ejection Fraction (LVEF) 6,12, and 24 months, and 3, 4, and 5 years Change in Left Ventricular End Ejection Fraction (LVEF) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow. 6, 12, and 24 months, and 3, 4, and 5 years Change in pulmonary vein flow MR severity as assessed by echocardiography in hospital, 6, 12, and 24 months, and 3, 4, and 5 years, in accordance with American Society of Echocardiography guidelines, compared to baseline.
Change in Left Atrial Diameter 6, 12, and 24 months, and 3, 4, and 5 years Change in Left Atrial Diameter as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in Left Ventricular End Systolic Volume (LVESV) 6,12, and 24 months, and 3, 4, and 5 years Change in Left Ventricular End Systolic Volume (LVESV) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in Left Ventricular End Diastolic Volume (LVEDV) 6,12, and 24 months, and 3, 4, and 5 years Change in Left Ventricular End Diastolic Volume (LVEDV) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in Left Ventricular End Systolic Diameter (LVESD) 6,12, and 24 months, and 3, 4, and 5 years Change in Left Ventricular End Systolic Diameter (LVESD) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in Left Ventricular End Diastolic Diameter (LVEDD) 6,12, and 24 months, and 3, 4, and 5 years Change in Left Ventricular End Diastolic Diameter (LVEDD) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline
Change in exercise tolerance by walking 6,12, and 24 months, and 3, 4, and 5 years Change in exercise tolerance as measured by meters walked in Six Minute Walk Test at 6,12, and 24 months, and 3, 4, and 5 years over baseline
Trial Locations
- Locations (19)
Sana Klinikum Lichtenberg
🇩🇪Berlin, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
St. Marien Krankenhaus- Ahaus Vreden
🇩🇪Ahaus, 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
Universitätsmedizin Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Rheinland Klinikum Neuss GmbH- Lukaskrankenhaus
🇩🇪Neuss, Germany
Josefs Hospital Wiesbaden
🇩🇪Wiesbaden, Germany