Clinical trial NCT05677568: The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Official title: The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Functional Mitral Regurgitation
Mitral Regurgitation
Keywords: Functional Mitral Regurgitation
Mitral Regurgitation
Cardiac Dimensions
Carillon Mitral Contour System
CINCH
CINCH FMR
Carillon
CMCS
Lead sponsor: Cardiac Dimensions Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 250 patients implanted with the Carillon implant.

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.

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

Primary outcomes:
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 12 months
measure: Death
timeFrame: 24 months
measure: Death
timeFrame: 3 years
measure: Death
timeFrame: 4 years
measure: Death
timeFrame: 5 years
measure: Serious adverse events
timeFrame: 6 months
measure: Serious adverse events
timeFrame: 12 months
measure: Change in New York Heart Association (NYHA) classification
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Rate of Heart Failure Hospitalizations
timeFrame: 6 months
measure: Rate of Heart Failure Hospitalizations
timeFrame: 12 months
measure: Rate of Heart Failure Hospitalizations
timeFrame: 24 months
measure: Rate of Heart Failure Hospitalizations
timeFrame: 3 years
measure: Rate of Heart Failure Hospitalizations
timeFrame: 4 years
measure: Rate of Heart Failure Hospitalizations
timeFrame: 5 years
Secondary outcomes:
measure: Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL)
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%)
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change of MR Severity via Quantitative MR Variable: effective regurgitant orifice area (cm2 EROA)
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax.
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change of MR severity: Semi-Quantitative Parameter: Change in pulmonary vein flow.
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Atrial Area
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Atrial Diameter
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Atrial Volume Index
timeFrame: 6, 12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Ventricular End Systolic Volume (LVESV)
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Ventricular End Systolic Diameter (LVESD)
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Ventricular End Diastolic Diameter (LVEDD)
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
measure: Change in Left Ventricular End Ejection Fraction (LVEF)
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
measure: Change in exercise tolerance by walking
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
measure: Change in Quality-of-Life Overall Score
timeFrame: 6,12, and 24 months, and 3, 4, and 5 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Ahaus
country: Germany
facility: St. Marien Krankenhaus- Ahaus Vreden
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Darmstadt
country: Germany
facility: Kardiovaskular Zentrum Darmstadt
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt
city: Frankfurt
country: Germany
facility: Universtitätsklinikum Frankfurt
city: Fritzlar
country: Germany
facility: Hostpital zum Heiligen Geist
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus GmbH- Hamburg
city: Hausham
country: Germany
facility: Krankenhaus Agatharied GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Neuss
country: Germany
facility: Rheinland Klinikum Neuss GmbH- Lukaskrankenhaus
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wiesbaden
country: Germany
facility: Josefs Hospital Wiesbaden
Study officials:
affiliation: Rheinland Klinikum Neuss GmbH Lukaskrankenhaus
name: Michael Haude, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: