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Mitral RegurgitationEXERCISE FMRNCT05040451

Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation

An observational study of Mitral Regurgitation, run by Cardiac Dimensions Pty Ltd.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation. This will be primarily evaluated by standard of care exercise testing and echocardiography. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Regurgitation
What is being tested?
Carillon Mitral Contour System
Type of treatment
Medical device
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2021to Sep 2023
Phase
Observational
Are there results?
None posted in the registry

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: Consent up to 150 subjects suffering from heart failure and presenting with functional mitral regurgitation in order to implant 30 subjects, plus up to 3 "roll-in" subjects per site

Who may be able to join

  • Mild-moderate-to-severe secondary MR (as assessed by qualitative, semi-quantitative and/or quantitative echocardiographic assessment (Zoghbi, JASE 2017)) in the setting of all of the following (a-d, below):
  • Symptomatic functional (secondary mitral regurgitation defined as both: 1+ (mild) 2+ (Moderate), or 3+ (Moderate/Severe)
  • Exacerbation of MR with exercise by at least one grade or 10 mm2 EROA
  • Left Ventricular Ejection Fraction ≤50% by Simpson's biplane technique
  • LVEDD >5.5 cm
  • New York Heart Association (NYHA) Class II, III or ambulatory IV heart failure
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  • Stable heart failure medication regimen for at least 30 days prior to index procedure
  • Patient deemed appropriate candidate for transcatheter mitral valve repair by the local multidisciplinary heart team
  • Subject meets anatomic screening criteria as determined by angiographic screening at the time of the index procedure to ensure that implant can be sized and placed in accordance with the Instructions for Use
  • Female subjects of child-bearing potential must have a negative serum βHCG test
  • Age ≥ 18 years old
  • The subject has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study

Who cannot join

  • Hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
  • Evidence of transient ischemic attack or stroke within three (3) months prior to intervention
  • Percutaneous coronary intervention in the last 30 days
  • Subjects expected to require any cardiac surgery, including surgery for coronary artery disease or for pulmonic, aortic, or tricuspid valve disease within one (1) year
  • Subjects expected to require any percutaneous coronary intervention within 30 days of the index procedure.
  • Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV), or anticipated need for cardiac resynchronization therapy (CRT) within twelve (12) months
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  • Presence of a coronary artery stent under the CS / GCV in the implant target zone
  • Presence of left atrial appendage (LAA) clot.
  • Presence of primary renal dysfunction or significantly compromised renal function as reflected by a serum creatinine > 2.2 mg/dL (194.5 μmol/L) OR estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
  • Poorly controlled atrial fibrillation or flutter, with poor ventricular rate control (> 100 bpm resting HR), or other poorly controlled symptomatic brady- or tachy-arrhythmias
  • Uncontrolled hypertension (BP > 180 mmHg systolic and/or >105 mmHg diastolic) or hypotension (BP < 90 mmHg systolic) at baseline
  • Presence of severe mitral annular calcification
  • Prior mitral valve surgery
  • Presence of a mechanical mitral heart valve, mitral bio-prosthetic valve or mitral annuloplasty ring
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Active endocarditis
  • Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic regurgitation
  • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than functional mitral regurgitation
  • Subjects with echocardiographic documentation of non-compaction cardiomyopathy with associated hypercontractility of the cardiac structures supporting the mitral annulus
  • Hemodynamic instability requiring inotropic support or mechanical heart circulatory support
  • Active infections requiring current antibiotic therapy
  • Severe right ventricular failure or severe tricuspid regurgitation
  • History of bleeding diathesis or coagulopathy, or subject who refuses blood transfusions
  • Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)
  • Allergy to contrast dye that cannot be pre-medicated
  • Pregnant or planning pregnancy within next 12 months.
  • Chronic severe pathology limiting survival to less than 12-months in the judgement of the investigator
  • Anticipated need of left ventricular assist device within twelve (12) months
  • Currently participating or has participated in another investigational study where the study primary endpoint was not reached at the time of screening
  • Patient requires emergent/emergency treatment for mitral regurgitation

About this study

Official title: The EXERCISE FMR Trial: An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation

Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation. This will be primarily evaluated by standard of care exercise testing and echocardiography. The purpose is to evaluate HFrEF CHF patients that may have mild to moderate-severe MR at rest but aggravated upon activity.

Read the detailed description

The EXERCISE FMR trial is a prospective, multi-center clinical trial.

The centers will utilize pre-screening of existing medical records to identify potentially eligible subjects. Once informed consent has been obtained, the subject will undergo standard of care assessments which include: Transthoracic echocardiography, transesophageal echocardiography (if necessary), and functional assessments (NYHA and KCCQ Quality of Life Questionnaire). Following final eligibility determination, eligible subjects will under the index procedure to implant the commercially available Carillon device (includes coronary sinus venogram) according to the Instructions for Use. Subject will be discharged following after standard of care discharge assessments are completed.

Implanted subjects will have follow-up assessments performed at 1 month, 6 months, and 12 months post index procedure. Most assessments performed as part of follow-up are intended to be standard of care at each institution. The only elements that may fall outside of standard of care would be the non-invasive assessments of TTE, 6-minute walk test and the questionnaire. Further, follow-up at 1 and 6 months may also not be common site practice.

Being tested
Carillon Mitral Contour System
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

    The Carillon Mitral Contour System (XE2) consists of the following components:

    • An implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV)
    • A delivery system which consists of a custom 9F delivery catheter and a handle assembly.

What is being measured

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

  1. Change in MR Volume

    Change in mitral regurgitant volume (mL) associated with the Carillon device from rest and exercise at 6 months post-implant, as compared to baseline

    Measured: 6 Months

Secondary outcomes (14)

  1. Change of MR Severity: Quantitative MR Variables

    MR severity as assessed by echocardiography in hospital, 1 month, 6 months and 12 months, in accordance with American Society of Echocardiography guidelines, compared to baseline. Quantitative MR variables to be assessed include regurgitant volume (mL), regurgitant fraction (%) and effective regurgitant orifice area (cm2, EROA) by Proximal Isovelocity Surface Area (PISA).

    Measured: 1, 6 & 12 Months

  2. Change of MR severity: Semi-Quantitative Parameter (1)

    Change in vena contract width. MR severity as assessed by echocardiography in hospital, 1 month, 6 months and 12 months, in accordance with American Society of Echocardiography guidelines, compared to baseline.

    Measured: 1, 6 & 12 Months

  3. Change of MR severity: Semi-Quantitative Parameter (2)

    Change in MV EVmax. MR severity as assessed by echocardiography in hospital, 1 month, 6 months and 12 months, in accordance with American Society of Echocardiography guidelines, compared to baseline.

    Measured: 1, 6 & 12 Months

  4. Change of MR severity: Semi-Quantitative Parameter (3)

    Change in pulmonary vein flow. MR severity as assessed by echocardiography in hospital, 1 month, 6 months and 12 months, in accordance with American Society of Echocardiography guidelines, compared to baseline.

    Measured: 1, 6 & 12 Months

  5. Change in Left Atrial Area

    Change in Left Atrial Area as assessed by echocardiography at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  6. Change in Left Atrial Diameter

    Change in Left Atrial Diameter as assessed by echocardiography at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  7. Change in Left Atrial Volume Index

    Change in Left Atrial Volume as assessed by echocardiography Index at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  8. Change in Left Ventricular End Systolic Volume (LVESV)

    Change in Left Ventricular End Systolic Volume (LVESV) as assessed by echocardiography at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  9. Change in Pulmonary Artery Systolic Pressure

    Change in Pulmonary Artery Systolic Pressure as assessed by echocardiography at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  10. Change in Quality-of-Life Overall Score

    Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  11. Change in NYHA

    Change in New York Heart Association (NYHA) Functional Classification at 1, 6 and 12 months over baseline

    Measured: 1, 6 & 12 Months

  12. Rate of Heart Failure Hospitalizations

    Rate of hospitalization for heart failure at 1, 6 and 12 months

    Measured: 1, 6 & 12 Months

  13. Rate of Major Cardiovascular Events

    Rate of stroke, myocardial infarction, cardiovascular and all-cause mortality at 1, 6 and 12 months

    Measured: 1, 6 & 12 Months

  14. Rate of Other Mitral Valve Interventions

    Number of participants in need of mitral valve intervention or surgery at 1, 6 and 12 months

    Measured: 1, 6 & 12 Months

Timeline

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

  1. First posted10 Sep 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Why it stopped: Lack patients and site resources for the proposed population

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
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05040451
Sponsor's protocol ID
CVP-3500-01
Acronym
EXERCISE FMR
Status last verified
Oct 2022
First submitted
13 May 2021
Last updated
7 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plans for sharing

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation, run by Cardiac Dimensions Pty Ltd.

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 12 inclusion and 31 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: withdrawn, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change in MR Volume (time frame: 6 Months). 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 NCT05040451.

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 7 Oct 2022.

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