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

Mitral Regurgitation Clinical Trial

— CINCH-FMR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05677568
• Other study ID #: PMS-1681-01
• Status: Enrolling by invitation
• Start date: June 24, 2017
• Est. completion date: June 30, 2030

Study information

• Verified date: March 2023
• Source: Cardiac Dimensions Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Carillon Mitral Contour System
The Cardiac Dimensions Carillon Mitral Contour System (CMCS) is a medical device and consists of the following components: A proprietary implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV) A catheter-based delivery system which consists of a curved CMCS delivery catheter (3.2mm outer diameter) and a handle assembly 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.

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Cardiac Dimensions, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	6 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	12 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	24 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	3 years
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	4 years
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	5 years
Primary	Serious adverse events	Number of procedure related or device related serious adverse events	6 months
Primary	Serious adverse events	Number of procedure related or device related serious adverse events	12 months
Primary	Change in New York Heart Association (NYHA) classification	Change in New York Heart Association (NYHA) Functional Classification at 6, 12, and 24 months, and 3, 4, and 5 years	6, 12, and 24 months, and 3, 4, and 5 years
Primary	Rate of Heart Failure Hospitalizations	Rate of hospitalization for heart failure	6 months
Primary	Rate of Heart Failure Hospitalizations	Rate of hospitalization for heart failure	12 months
Primary	Rate of Heart Failure Hospitalizations	Rate of hospitalization for heart failure	24 months
Primary	Rate of Heart Failure Hospitalizations	Rate of hospitalization for heart failure	3 years
Primary	Rate of Heart Failure Hospitalizations	Rate of hospitalization for heart failure	4 years
Primary	Rate of Heart Failure Hospitalizations	Rate of hospitalization for heart failure	5 years
Secondary	Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL)	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.	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%)	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.	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change of MR Severity via Quantitative MR Variable: effective regurgitant orifice area (cm2 EROA)	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.	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width	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.	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax.	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.	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow.	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.	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Atrial Area	Change in Left Atrial Area as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Atrial Diameter	Change in Left Atrial Diameter as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Atrial Volume Index	Change in Left Atrial Volume as assessed by echocardiography Index at 6, 12, and 24 months, and 3, 4, and 5 years over baseline	6, 12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Ventricular End Systolic Volume (LVESV)	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	6,12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Ventricular End Diastolic Volume (LVEDV)	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	6,12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Ventricular End Systolic Diameter (LVESD)	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	6,12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Ventricular End Diastolic Diameter (LVEDD)	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	6,12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Left Ventricular End Ejection Fraction (LVEF)	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	6,12, and 24 months, and 3, 4, and 5 years
Secondary	Change in exercise tolerance by walking	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	6,12, and 24 months, and 3, 4, and 5 years
Secondary	Change in Quality-of-Life Overall Score	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	6,12, and 24 months, and 3, 4, and 5 years