Early Feasibility Study of the AccuCinch® Ventricular Restoration System (5018) in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
About
Protocol Description
The objective of this trial is to evaluate the safety and performance of the AccuCinch system in patients with recurrent MR after PMVI. Enrollment has closed.
Find additional information here.
Eligibility Criteria
Inclusion Criteria
- Study patient is at least 18 years old
- Severity of FMR: ≥Moderate
- Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
- LV ejection fraction: ≥20 to ≤40%
- Symptom status: NYHA II-IVa (i.e., ambulatory)
- Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blockers (ARB) for 1 month, with "stable" defined as no greater than 100% increase or 50% decrease in medication doses. Treatment shall include CRT and/or ICD when indicated by guidelines.
Exclusion Criteria
See inclusion criteria.
Primary Investigator
Jason Foerst, M.D.
Medical director of the Structural Heart and Valve Center at Carilion Clinic and an assistant professor of Medicine at the Virginia Tech Carilion School of Medicine.
Contact Information
Christina Bryant, R.N., R.C.I.S.
Clinical Research Nurse Coordinator
