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Not yet recruiting NCT07296016

The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry

Observational Structural Heart Disease Mitral Valve Regurgitation

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: Structural Heart Disease, Mitral Valve Regurgitation. 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
Hong Kong
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 significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves. Over time, these bioprosthetic valves and rings may fail resulting in recurrence of the valvular disease. The technical aspects of a re-do operation are complex and these patients are often times at high risk for repeat open surgery. The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery. Majority of the data currently exist for Western cohorts with limited longer-term outcomes. Data on this therapy is particularly lacking in the Asia-Pacific region, especially important in the light of known differences in body habitus and size.

Primary outcome measures

  • All-cause mortality [Time frame: 10 years]
Secondary outcome measures (5)
  • Procedural technical success rate [Time frame: Immediately after operation]
  • Procedural complication rate [Time frame: Periprocedural]
  • Major adverse cardiovascular events rate [Time frame: 10 years]
  • New York Heart Association (NYHA) classification [Time frame: 10 years]
  • Echocardiographic result [Time frame: 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
Cohort

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT07296016 · 2025.502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗