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

NCT05677568 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: PMS-1681-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 19

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.

Conditions

Functional Mitral Regurgitation; Mitral Regurgitation

Keywords

Functional Mitral Regurgitation; Mitral Regurgitation; Cardiac Dimensions; Carillon Mitral Contour System; CINCH; CINCH FMR; Carillon; CMCS

Outcome Measures

Primary Outcomes (15)

• Death

  All cause mortality including cardiovascular and non-cardiovascular death

  6 months

• Death

  All cause mortality including cardiovascular and non-cardiovascular death

  12 months

• Death

  All cause mortality including cardiovascular and non-cardiovascular death

  24 months

• Death

  All cause mortality including cardiovascular and non-cardiovascular death

  3 years

• Death

  All cause mortality including cardiovascular and non-cardiovascular death

  4 years

• Death

  All cause mortality including cardiovascular and non-cardiovascular death

  5 years

• Serious adverse events

  Number of procedure related or device related serious adverse events

  6 months

• Serious adverse events

  Number of procedure related or device related serious adverse events

  12 months

• 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

• Rate of Heart Failure Hospitalizations

  Rate of hospitalization for heart failure

  6 months

• Rate of Heart Failure Hospitalizations

  Rate of hospitalization for heart failure

  12 months

• Rate of Heart Failure Hospitalizations

  Rate of hospitalization for heart failure

  24 months

• Rate of Heart Failure Hospitalizations

  Rate of hospitalization for heart failure

  3 years

• Rate of Heart Failure Hospitalizations

  Rate of hospitalization for heart failure

  4 years

• Rate of Heart Failure Hospitalizations

  Rate of hospitalization for heart failure

  5 years

Secondary Outcomes (16)

• Change of MR Severity via Quantitative MR Variable: regurgitant volume (mL)

  6, 12, and 24 months, and 3, 4, and 5 years

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

  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)

  6, 12, and 24 months, and 3, 4, and 5 years

• Change of MR severity: Semi-Quantitative Parameter: Change in vena contract width

  6, 12, and 24 months, and 3, 4, and 5 years

• Change of MR severity: Semi-Quantitative Parameter: Change in MV EVmax.

  6, 12, and 24 months, and 3, 4, and 5 years

Study Arms (2)

Prospective

"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.

Device: Carillon Mitral Contour System

Retrospective/Prospective

"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.

Device: Carillon Mitral Contour System

Interventions

Carillon Mitral Contour System DEVICE

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 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.

Also known as: Cardiac Dimensions, CMCS

Prospective; Retrospective/Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 250 patients implanted with the Carillon implant.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Cardiac Dimensions, Inc.: lead

Study Sites (19)

Universitätsklinikum Aachen

Aachen, Germany

Location

St. Marien Krankenhaus- Ahaus Vreden

Ahaus, Germany

Location

Sana Klinikum Lichtenberg

Berlin, Germany

Location

Klinikum Links der Weser

Bremen, Germany

Location

Kardiovaskular Zentrum Darmstadt

Darmstadt, Germany

Location

Herzzentrum Dresden

Dresden, Germany

Location

Cardiovascular Center Frankfurt

Frankfurt, Germany

Location

Universtitätsklinikum Frankfurt

Frankfurt, Germany

Location

Hostpital zum Heiligen Geist

Fritzlar, Germany

Location

Asklepios Klinik Altona

Hamburg, Germany

Location

Kath. Marienkrankenhaus GmbH- Hamburg

Hamburg, Germany

Location

Krankenhaus Agatharied GmbH

Hausham, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Germany

Location

Rheinland Klinikum Neuss GmbH- Lukaskrankenhaus

Neuss, 41464, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Josefs Hospital Wiesbaden

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Haude, Prof. Dr.

  Rheinland Klinikum Neuss GmbH Lukaskrankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: January 10, 2023
• Study Start: June 24, 2017
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (19)