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MitraClip NT System Post-marketing Surveillance Study - Japan — MitraClip NT  

Mitral Regurgitation Clinical Trial

Official title:
MitraClip NT System Post -Marketing Surveillance Study

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03500692
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date April 2, 2018
Completion date March 23, 2022
View Details
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