The China Mviv Registry

Status Recruiting

Clinical Trial Summary

Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..

Clinical Trial Description

Due to a massive shift from mechanical to bioprosthetic valves with finite longevity, increasing numbers of patients are presenting with bioprosthetic mitral valve degeneration. Mitral valve reoperation, the standard therapy for the bioprosthetic failure in the past, often entails high risk due to age, multiple comorbidities et al. TMVR is an emerging treatment for the patients with bioprosthetic failure at high risk for conventional mitral valve surgery. Recent studies from US and Europe have demonstrated the safety and efficacy of TMVR in this population. However, there are limited data regarding clinical outcomes after TMVR from Asia-Pacific region. To evaluate the safety and efficacy of TMVR using balloon-expandable valve among those patients with high risk for redo surgery and those who refuse redo surgery after shared decision making even they have less than high risk. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05925335
Study type	Interventional
Source	Xiamen Cardiovascular Hospital, Xiamen University
Contact	Xiang Chen, Dr
Phone	18033997788
Email	Seanchenx@126.com
Status	Recruiting
Phase	N/A
Start date	July 11, 2023
Completion date	June 11, 2025

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