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Recruiting NCT07058935

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

Observational Valve Disease, Heart

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Valve Disease, Heart. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Hong Kong, India, New Zealand, Singapore +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • All-cause mortality [Time frame: From date of procedure to 10 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Hong Kong · 2 centers
  • Prince of Wales Hospital — Hong Kong
  • Queen Elizabeth Hospital — Hong Kong
India · 2 centers
  • MGM Healthcare Pvt Ltd — Chennai
  • The Madras Medical Mission — Chennai
Australia · 1 center
  • John Hunter Hospital — New Lambton Heights
New Zealand · 1 center
  • Waikato Hospital — Hamilton
Singapore · 1 center
  • National Heart Centre Singapore — Singapore
Thailand · 1 center
  • Ramathibodi Hospital — Bangkok

Identifiers

NCT: NCT07058935 · 2024-4264

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗