NCT03142152 The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
| NCT ID | NCT03142152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cardiac Dimensions, Inc. |
| Condition | Functional Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2018-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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
Contact & Investigator
Samir Kapadia, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT03142152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Functional Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03142152 currently recruiting?
Yes, NCT03142152 is actively recruiting participants. Contact the research team at hhauser@cardiacdimensions.com for enrollment information.
Where is the NCT03142152 trial being conducted?
This trial is being conducted at Gilbert, United States, Phoenix, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT03142152 clinical trial?
NCT03142152 is sponsored by Cardiac Dimensions, Inc.. The principal investigator is Samir Kapadia, MD at The Cleveland Clinic. The trial plans to enroll 300 participants.