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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07058935




Registration number
NCT07058935
Ethics application status
Date submitted
1/07/2025
Date registered
10/07/2025
Date last updated
10/07/2025

Titles & IDs
Public title
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
Scientific title
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
Secondary ID [1] 0 0
2024-4264
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Valve Disease, Heart 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Mitral Valve-in-Valve - Patients who have undergone or will undergo a transcatheter mitral valve-in-valve procedure.

Mitral Valve-in-Ring - Patients who have undergone or will undergo a transcatheter mitral valve-in-ring procedure.

Tricuspid Valve-in-Valve - Patients who have undergone or will undergo a transcatheter tricuspid valve-in-valve procedure.

Tricuspid Valve-in-Ring - Patients who have undergone or will undergo a transcatheter tricuspid valve-in-ring procedure.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
From date of procedure to 10 years

Eligibility
Key inclusion criteria
1. Age = 21
2. Had at least one documented Mitral valve-in-valve/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/valve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve/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/valve-in-ring procedure. (Prospective)
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active endocarditis
2. Any other conditions which investigator deems unsuitable for participation.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2035
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
- New Lambton Heights
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
India
State/province [2] 0 0
Tamil Nadu
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
Singapore
State/province [4] 0 0
Singapore
Country [5] 0 0
Thailand
State/province [5] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
National Heart Centre Singapore
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Edwards Lifesciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Deborah Yip
Address 0 0
Country 0 0
Phone 0 0
+65-67042301
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07058935