Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-02 @ 8:05 PM
Study NCT ID:
NCT05925335
Status:
UNKNOWN
Last Update Posted:
2023-06-29
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The China Mviv Registry
Sponsor:
Xiamen Cardiovascular Hospital, Xiamen University
Organization:
Study Overview
Official Title:
Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: