NCT03142152

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cardiac Dimensions, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 cardiac vein (CS/GCV) for placement of the Carillon implant. If the subject meets the anatomic requirements for the Carillon implant placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control). Subjects randomized to the Intervention group will undergo the Carillon implant procedure. Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without implant placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure. After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status. After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact and echocardiogram for an additional three (3) years, for a total of five (5) years.

Conditions

• Functional Mitral Regurgitation
• Heart Failure
• Mitral Valve Insufficiency
• Heart Diseases
• Cardiovascular Diseases
• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	Carillon 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.
OTHER	Guideline Directed Heart Failure Medication	Heart failure medication per ACC/AHA guidelines

Timeline

• Start date: 2018-01-01
• Primary completion: 2026-12-31
• Completion: 2030-12-31
• First posted: 2017-05-05
• Last updated: 2026-04-13

Locations

92 sites across 8 countries: United States, Canada, France, Greece, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study