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Safety and Performance Study of the MitralStitch Repair System.

2019-09-12 02:34:41 | BioPortfolio

Summary

The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.

Description

The clinical trial was designed as a prospective, multicenter, single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transapical beating-heart mitral valve repair surgery using MitralStitch mitral valve repair system after signed the informed consent. The follow-up will be conducted after 30 days, 3 months, 6 months and 12 months of the operation.

The following conditions evaluate the performance of the system and the safety and efficiency of using MitralStitch mitral valve repair system in treating patients with severe mitral regurgitation.

The none occurrence of these conditions will be approved as the main validity index: death, mitral valve related surgery without mitral valve failure and moderate or severe mitral regurgitation (MR > 2+). The secondary validity index was technical success rate, instrument success rate, surgical success rate, cardiac function improvement and quality of life improvement. And the safety evaluation indicators were assessed by the incidence of major adverse events, adverse events, serious adverse events, and device defects.

Study Design

Conditions

Mitral Regurgitation

Intervention

MitralStitch

Location

Structural Heart Disease Center, Fuwai Hospital
Beijing
Beijing
China

Status

Enrolling by invitation

Source

Hangzhou Valgen Medtech Co., Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-12T02:34:41-0400

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Medical and Biotech [MESH] Definitions

Backflow of blood from the LEFT VENTRICLE into the LEFT ATRIUM due to imperfect closure of the MITRAL VALVE. This can lead to mitral valve regurgitation.

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