NCT03500692

MitraClip NT System Post-marketing Surveillance Study - Japan

MitraClip NT System Post -Marketing Surveillance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mitral Regurgitation
• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	MitraClip NT System	Percutaneous mitral valve repair using MitraClip NT System

Timeline

• Start date: 2018-04-02
• Primary completion: 2019-03-31
• Completion: 2022-03-23
• First posted: 2018-04-18
• Last updated: 2024-07-23
• Results posted: 2021-04-15

Locations

40 sites across 1 country: Japan