Accucinch

STUDY IDENTIFIER:

Accucinch

CONDITION:

Functional mitral regurgitation

CONTACT INFO:

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

DESCRIPTION:

The objective of this trial is to evaluate the safety and performance of the investigational AccuCinch System and assess the indices of heart failure and functional mitral regurgitation in symptomatic adult patients with mitral regurgitaion and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

CRITERIA LIST/ QUALIFICATIONS:

  • Severity of FMR: ≥ Moderate.
  • Ejection Fraction: ≥20 to ≤60%.
  • Symptom Status: NYHA II-IVa.

INVESTIGATORS:

Paul Sorajja, MD

SPONSORS:

Ancora Heart, Inc.

STATUS:

Open/Enrolling