AccuCinch 5018 PMVI

STUDY IDENTIFIER:

AccuCinch 5018 PMVI

CONDITION:

Functional Mitral Valve Regurgitation after mitral valve intervention

CONTACT INFO:

Sara Olson, RN   |   sara.olson@allina.com   |   612-863-7601

DESCRIPTION:

This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

CRITERIA LIST/ QUALIFICATIONS:

 
  1. Severity of FMR: ≥Moderate  (i.e. 2+)
  2. Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
  3. LV ejection fraction: ≥20 to ≤40%
  4. Symptom status: NYHA II-IVa

INVESTIGATORS:

Paul Sorajja, MD

SPONSORS:

Ancora Heart

STATUS:

Open/Enrolling

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