NCT07058935

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
116mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
6 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2025Dec 2035

Study Start

First participant enrolled

March 17, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

10.7 years

First QC Date

July 1, 2025

Last Update Submit

July 1, 2025

Conditions

Valve Disease, Heart

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    From date of procedure to 10 years

Study Arms (4)

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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

John Hunter Hospital

New Lambton Heights, Australia

NOT YET RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Elizabeth Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

MGM Healthcare Pvt Ltd

Chennai, Tamil Nadu, India

NOT YET RECRUITING

The Madras Medical Mission

Chennai, Tamil Nadu, India

NOT YET RECRUITING

Waikato Hospital

Hamilton, New Zealand

NOT YET RECRUITING

National Heart Centre Singapore

Singapore, Singapore

RECRUITING

Ramathibodi Hospital

Bangkok, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Deborah Yip

CONTACT

+65-67042301deborah.yip.x.y@singhealth.com.sg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 10, 2025

Study Start

March 17, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)IN(2)SG(1)NZ(1)AU(1)TH(1)