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Functional Mitral RegurgitationCINCH-FMRNCT05677568

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

An observational study of Functional Mitral Regurgitation and Mitral Regurgitation, run by Cardiac Dimensions, Inc. at 19 sites in Germany.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carillon Mitral Contour System
Type of treatment
Medical device
How many people
250 participants
Where
19 sitesGermany
Study dates
24 Jun 2017to 30 Jun 2030
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Up to 250 patients implanted with the Carillon implant.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

19 sites in 1 country

Germany19 sites

  • Universitätsklinikum Aachen

    Aachen

  • St. Marien Krankenhaus- Ahaus Vreden

    Ahaus

  • Sana Klinikum Lichtenberg

    Berlin

  • Klinikum Links der Weser

    Bremen

  • Kardiovaskular Zentrum Darmstadt

    Darmstadt

  • Herzzentrum Dresden

    Dresden

  • Cardiovascular Center Frankfurt

    Frankfurt

  • Universtitätsklinikum Frankfurt

    Frankfurt

  • Hostpital zum Heiligen Geist

    Fritzlar

  • Asklepios Klinik Altona

    Hamburg

  • Kath. Marienkrankenhaus GmbH- Hamburg

    Hamburg

  • Krankenhaus Agatharied GmbH

    Hausham

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsmedizin Mainz

    Mainz

  • Universitätsmedizin Mannheim

    Mannheim

  • Rheinland Klinikum Neuss GmbH- Lukaskrankenhaus

    Neuss, 41464

  • Universitätsklinikum Ulm

    Ulm

  • Josefs Hospital Wiesbaden

    Wiesbaden

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Carillon Mitral Contour System
Keywords
Functional Mitral Regurgitation, Mitral Regurgitation, Cardiac Dimensions, Carillon Mitral Contour System, CINCH, CINCH FMR, Carillon, CMCS
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carillon Mitral Contour SystemDevice

    Also called Cardiac Dimensions, CMCS

    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.
Study groups in NCT05677568
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Device: Carillon Mitral Contour System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    All cause mortality including cardiovascular and non-cardiovascular death

    Measured: 6 months

  2. Death

    All cause mortality including cardiovascular and non-cardiovascular death

    Measured: 12 months

  3. Death

    All cause mortality including cardiovascular and non-cardiovascular death

    Measured: 24 months

  4. Death

    All cause mortality including cardiovascular and non-cardiovascular death

    Measured: 3 years

  5. Death

    All cause mortality including cardiovascular and non-cardiovascular death

    Measured: 4 years

  6. Death

    All cause mortality including cardiovascular and non-cardiovascular death

    Measured: 5 years

  7. Serious adverse events

    Number of procedure related or device related serious adverse events

    Measured: 6 months

  8. Serious adverse events

    Number of procedure related or device related serious adverse events

    Measured: 12 months

  9. 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

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

  10. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure

    Measured: 6 months

  11. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure

    Measured: 12 months

  12. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure

    Measured: 24 months

  13. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure

    Measured: 3 years

  14. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure

    Measured: 4 years

  15. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure

    Measured: 5 years

Secondary outcomes (16)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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

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

  8. 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

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

  9. 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

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

  10. 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

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

  11. 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

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

  12. 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

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

  13. 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

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

  14. 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

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

  15. 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

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

  16. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start24 Jun 2017
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
250 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677568
Sponsor's protocol ID
PMS-1681-01
Acronym
CINCH-FMR
Status last verified
Mar 2023
First submitted
20 Oct 2022
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No plans for sharing

Questions about this trial

What is this clinical trial studying?

An observational study of Functional Mitral Regurgitation and Mitral Regurgitation, run by Cardiac Dimensions, Inc. at 19 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: 6 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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