Actively Recruiting
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
Led by National Heart Centre Singapore · Updated on 2025-07-10
150
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Heart Centre Singapore
Lead Sponsor
E
Edwards Lifesciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a retrospective and prospective observational study involving patients who have undergone or are planning to undergo transcatheter mitral or tricuspid valve-in-valve or valve-in-ring procedures with balloon expandable valves. This multicenter cohort study takes place across various sites in the Asia-Pacific region and aims to collect detailed information about these valve procedures in patients with heart valve disease. The study includes four groups of patients: those who have had or will have a mitral valve-in-valve procedure, a mitral valve-in-ring procedure, a tricuspid valve-in-valve procedure, or a tricuspid valve-in-ring procedure. These procedures involve the placement of balloon expandable valves in the mitral or tricuspid positions either within an existing valve (valve-in-valve) or within a ring (valve-in-ring). Participants will be followed up to measure all-cause mortality from the date of their procedure for up to 10 years. Data will be collected retrospectively for past procedures since January 1, 2023, and prospectively for planned procedures. This long-term follow-up will help researchers understand outcomes after these specific valve procedures. Participants can expect their health status to be monitored over time with no additional intervention as part of this observational registry.
CONDITIONS
Brief Title
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- Had at least one documented mitral valve-in-valve or valve-in-ring procedure since January 1, 2023, or planned to undergo such a procedure
- Had at least one documented tricuspid valve-in-valve or valve-in-ring procedure since January 1, 2023, or planned to undergo such a procedure
You will not qualify if you...
- Active endocarditis
- Any other conditions that the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies depending on timing of procedure
Participants undergo or have undergone a transcatheter mitral or tricuspid valve-in-valve or valve-in-ring procedure.
1 to 2 visits depending on procedure timing
Duration - Up to 10 years
Participants are observed for up to 10 years following their valve procedure to monitor all-cause mortality and health status.
Periodic follow-up visits over 10 years
Trial Site Locations
Total: 8 locations
1
John Hunter Hospital
New Lambton Heights, Australia
Not Yet Recruiting
2
Prince of Wales Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
3
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
4
MGM Healthcare Pvt Ltd
Chennai, Tamil Nadu, India
Not Yet Recruiting
5
The Madras Medical Mission
Chennai, Tamil Nadu, India
Not Yet Recruiting
6
Waikato Hospital
Hamilton, New Zealand
Not Yet Recruiting
7
National Heart Centre Singapore
Singapore, Singapore
Actively Recruiting
8
Ramathibodi Hospital
Bangkok, Thailand
Not Yet Recruiting
Research Team
D
Deborah Yip
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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