Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation
Cardiac Dimensions, Inc.
Summary
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
Description
A total of 300 subjects will be randomized at up to 100 investigational sites in the United States, Canada, and Europe. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio. Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great car…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DeviceCarillon Mitral Contour System
The Carillon implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
- OtherGuideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines
Locations (92)
- Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical CentersGilbert, Arizona
- Banner Health - PhoenixPhoenix, Arizona
- AZ Heart RhythmPhoenix, Arizona
- Tucson Medical Center HealthTucson, Arizona
- Banner University TusconTucson, Arizona
- Memorial Care HospitalLong Beach, California