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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
  Gilbert, Arizona, United States Recruiting
• Banner Health - Phoenix
  Phoenix, Arizona, United States Recruiting
• Tucson Medical Center Health
  Tucson, Arizona, United States Recruiting
• Banner University Tuscon
  Tucson, Arizona, United States Recruiting
• Keck School of Medicine of USC
  Los Angeles, California, United States Recruiting
• UCLA Medical Center
  Los Angeles, California, United States Recruiting

+42 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Samir Kapadia, MD — The Cleveland Clinic
• Study coordinator: Hank Hauser
• Email: hhauser@cardiacdimensions.com
• Phone: (310) 228-0016

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.