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Enrolling by Invitation

NCT Number: NCT05677568

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

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.

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Key information

Conditions

Functional Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Aachen, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carillon Mitral Contour System

Device

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.

Other names: Cardiac Dimensions, CMCS

Primary outcomes

  1. Death

    Time frame: 6 months

    All cause mortality including cardiovascular and non-cardiovascular death

  2. Death

    Time frame: 12 months

    All cause mortality including cardiovascular and non-cardiovascular death

  3. Death

    Time frame: 24 months

    All cause mortality including cardiovascular and non-cardiovascular death

  4. Death

    Time frame: 3 years

    All cause mortality including cardiovascular and non-cardiovascular death

  5. Death

    Time frame: 4 years

    All cause mortality including cardiovascular and non-cardiovascular death

  6. Death

    Time frame: 5 years

    All cause mortality including cardiovascular and non-cardiovascular death

  7. Serious adverse events

    Time frame: 6 months

    Number of procedure related or device related serious adverse events

  8. Serious adverse events

    Time frame: 12 months

    Number of procedure related or device related serious adverse events

  9. Change in New York Heart Association (NYHA) classification

    Time frame: 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

  10. Rate of Heart Failure Hospitalizations

    Time frame: 6 months

    Rate of hospitalization for heart failure

  11. Rate of Heart Failure Hospitalizations

    Time frame: 12 months

    Rate of hospitalization for heart failure

  12. Rate of Heart Failure Hospitalizations

    Time frame: 24 months

    Rate of hospitalization for heart failure

  13. Rate of Heart Failure Hospitalizations

    Time frame: 3 years

    Rate of hospitalization for heart failure

  14. Rate of Heart Failure Hospitalizations

    Time frame: 4 years

    Rate of hospitalization for heart failure

  15. Rate of Heart Failure Hospitalizations

    Time frame: 5 years

    Rate of hospitalization for heart failure

Secondary outcomes

  1. 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 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.

  2. Change of MR Severity via Quantitative MR Variable: regurgitant fraction (%)

    Time frame: 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.

  3. 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 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.

  4. 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 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.

  5. 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 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. 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 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.

  7. Change in Left Atrial Area

    Time frame: 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

  8. Change in Left Atrial Diameter

    Time frame: 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

  9. Change in Left Atrial Volume Index

    Time frame: 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

  10. 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 Systolic Volume (LVESV) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline

  11. 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 Diastolic Volume (LVEDV) as assessed by echocardiography at 6, 12, and 24 months, and 3, 4, and 5 years over baseline

  12. Change in Left Ventricular End Systolic Diameter (LVESD)

    Time frame: 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

  13. Change in Left Ventricular End Diastolic Diameter (LVEDD)

    Time frame: 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

  14. Change in Left Ventricular End Ejection Fraction (LVEF)

    Time frame: 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

  15. Change in exercise tolerance by walking

    Time frame: 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

  16. Change in Quality-of-Life Overall Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cardiac Dimensions, Inc.

Industry

Registry information

Acronym: CINCH-FMR

Important dates

Study start
2017
Primary completion
2025
Study completion
2030
First posted
Jan 10, 2023
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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