NCT05925335

The China Mviv Registry

Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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..

Detailed 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.

Conditions

• Bioprosthesis Failure
• Mitral Stenosis With Insufficiency
• Mitral Stenosis
• Mitral Regurgitation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Transseptal Transcatheter Mitral valve-in-valve Replacement	Transcatheter transfemoral mitral valve-in-valve replacement is an alternative surgery in patients with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The procedure is performed via femoral vein access. All procedures were carried out using intra-procedural TEE guidance to aid in transseptal puncture. After balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle and expanded in the mitral position during rapid ventricle pacing.

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-07-11
• Completion: 2025-06-11
• First posted: 2023-06-29
• Last updated: 2023-06-29

Locations

1 site across 1 country: China