Assessment of the Carillon Mitral Contour System in Treating Heart Failure with Functional Mitral Regurgitation: The EMPOWER Trial
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
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
Inclusion Criteria:
Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
NYHA II, III, or IV
Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
Left Ventricular Ejection Fraction ≤ 50%
LVEDD:
- ≥ 55 mm (women)
- ≥ 57 mm (men)
LVESD ≤ 75 mm
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.
Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
Age ≥ 18 years old
Carillon implant can be sized and placed in accordance with the IFU
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:
Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
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)
Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
Severe mitral annular calcification
Severe aortic stenosis
Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
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