Reshape-HF2

Study Objective

To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in symptomatic patients with chronic heart failure in NYHA Functional Class II, III or IV.

Study Design

•  Prospective, randomized, parallel-controlled, multi-center clinical trial
•  Investigator Initiated Trial (IIT)
•  Academic Principal Investigators: Prof. S. Anker, Prof. P. Ponikowski
•  Clinical Lead: Prof. W. Schillinger
•  Statistician: Prof. T. Friede
•  Sponsor: University Medical Center, Göttingen (UMG) Germany
•  Sample Size: Approximately 650 subjects
•  Randomization in a 1:1 ratio to the Device group or Control Group

Study Timelines

•  Recruitment period end: approximately end 2022
•  After the 12-month visit, patients will be scheduled for follow-up visits in 12-months intervals, i.e. at 24, 36, 48 months and so on
•  The duration of the study including an extension study will be up to 10 years for each patient, and circa 13 years in total
•  Time-points for secondary statistical reports on all endpoints will be when all patients have at least 3, 5 and 10 years of follow-up, respectively

Echo Core Lab

Universitätsmedizin der Johannes Gutenberg-Universität Mainz
(University Medical Center of the Johannes Gutenberg University Mainz)
– Dr. Ralph Stephan von Bardeleben
– Dr. Martin Geyer