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Using the Carillon Mitral Contour System to treat heart failure with mild functional mitral regurgitation

Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation

Not applicable Interventional Cardiac Dimensions Pty Ltd · NCT03142152

This study is testing if the Carillon Mitral Contour System can help people with heart failure and mild mitral regurgitation feel better compared to a similar procedure without the device.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorCardiac Dimensions Pty Ltd Industry-sponsored
Locations92 sites (Gilbert, Arizona and 91 other locations)
Trial IDNCT03142152 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the Carillon Mitral Contour System in patients suffering from heart failure with at least mild functional mitral regurgitation. A total of 300 participants will be randomly assigned to either receive the Carillon implant or undergo a similar procedure without the device. Prior to randomization, participants will undergo echocardiographic examinations and angiograms to ensure they meet the anatomical requirements for the device placement. Follow-up evaluations will be coordinated by their primary care specialists to monitor outcomes over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic heart failure and at least mild functional mitral regurgitation.

Not a fit: Patients with pre-existing devices in the coronary sinus or those with Class I indications for cardiac resynchronization therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart failure symptoms and quality of life for patients with functional mitral regurgitation.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating heart failure with device-based interventions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
2. NYHA II, III, or IV
3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
4. Left Ventricular Ejection Fraction ≤ 50%
5. LVEDD:

   * ≥ 55 mm (women)
   * ≥ 57 mm (men)
6. LVESD ≤ 75 mm
7. Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.
8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
9. Age ≥ 18 years old
10. Carillon implant can be sized and placed in accordance with the IFU
11. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent

Exclusion Criteria:

1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
2. 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)
3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
4. Severe mitral annular calcification
5. Severe aortic stenosis
6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study

   * An entire list of eligibility is available in the clinical investigational plan

Where this trial is running

Gilbert, Arizona and 91 other locations

+42 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Functional Mitral RegurgitationHeart FailureMitral Valve InsufficiencyHeart DiseasesCardiovascular DiseasesHeart Valve DiseasesPercutaneous Mitral Valve RepairPercutaneous Mitral Valve Annuloplasty
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.