The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-... | NCT07058935

Studies
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)

NCT07058935

Sponsor

National Heart Centre Singapore

Status

Recruiting

Last Update Posted

Jul 10, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Valve Disease, Heart

Interventions

Not provided

Countries

Australia
Hong Kong
India
New Zealand
Singapore
Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2025Actual

Primary Completion Date

Dec 2035Estimated

Completion Date

Dec 2035Estimated

First Submitted Date

Jul 1, 2025

First Submission Date that Met QC Criteria

Jul 1, 2025

First Posted Date

Jul 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2025

Last Update Posted Date

Jul 10, 2025Actual

Name	Class
Edwards Lifesciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in Asia-Pacific.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
All-cause mortality		From date of procedure to 10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 21
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)

Exclusion Criteria:

Active endocarditis
Any other conditions which investigator deems unsuitable for participation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in Asia-Pacific from 1 Jan 2023 to 31 Dec 2035.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Deborah Yip	Contact	+65-67042301		deborah.yip.x.y@singhealth.com.sg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John Hunter Hospital	Not yet recruiting	New Lambton Heights			Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided