MitraClip NT System Post-marketing Surveillance Study - Japan
MitraClip NT System Post-marketing Surveillance Study - Japan
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the
 frequency, type and degree of adverse device effects and adverse events in order to assure
 the safety of the new medical device, and to collect safety and efficacy information for
 evaluating the results of the clinical use.
This study is a prospective, mutli-center, single-arm post-marketing clinical use
 surveillance study. The Surveillance will consecutively register patients with moderate to
 severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was
 attempted. Patients registered in the AVJ-514 clinical trial who received additional
 MitraClip procedures will be excluded from the Surveillance.

 Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3
 years in Japanese medical centers.
Inclusion Criteria: Refer to MitraClip IFU

 Exclusion Criteria: Refer to MitraClip IFU