The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,500
- Locations
- 2
- Primary Endpoint
- All-cause mortality
Study Overview
Brief Summary
This study is a retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral or tricuspid ViV or ViR procedure with balloon expandable valve.The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery.So hence, since the data on this therapy is particularly lacking in the Asia-Pacific region, especially importantly in the light of known differences in body habitus and size- the main aim of the study is to: Describe the real-world use of transcatheter mitral or tricuspid ViV/ViR in Asia-Pacific, determine predictors of procedural success, determine predictors of major procedural complications and to evaluate short or intermediate or long term safety and efficacy outcomes and its determinants.Data related to patient’s procedure will be collected and stored at the National Heart Centre Singapore (NHCS). Statistical analyses will be conducted using Stata version 16.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 21.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age equal to or more than 21
- •Had at least one documented Mitral valve-in-valve or valve-in-ring procedure done during the period of 1 Jan 2023 to current date.
- •(Retrospective) OR Planned to undergo a Mitral valve-in-valve or valve-in-ring procedure.
- •(Prospective) OR Had at least one documented Tricuspid valve-in-valve or valve-in-ring procedure done during the period of 1 Jan 2023 to current date.
- •(Retrospective) OR Planned to undergo a Tricuspid valve-in-valve or valve-in-ring procedure.
- •(Prospective).
Exclusion Criteria
- •Active endocarditis
- •Any other conditions which investigator deems unsuitable for participation.
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: Ongoing up to 13 years
Secondary Outcomes
- Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure)(Ongoing up to 13 years)
- Procedural or In-hospital complications(Ongoing up to 13 years)
- Major adverse cardiovascular events (Cardiovascualr mortality, Myocardial Infraction, stroke,etc)(Ongoing up to 13 years)
- The New York Heart Association (NYHA) class(Ongoing up to 13 years)
- Echocardiographic variables(Ongoing up to 13 years)
Investigators
Dr Ajit MullasariS
The Madras Medical Mission