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

P

Prince of Wales Hospital

Status

Not yet enrolling

Conditions

Mitral Valve Regurgitation
Structural Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT07296016
2025.502

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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)

Exclusion criteria

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

Trial design

15 participants in 2 patient groups

Prospective
Description:
Patient planned to undergo a Mitral valve-in-valve/valve-in-ring procedure.
Retrospective
Description:
Patient that had at least one documented Mitral valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date.

Trial contacts and locations

1

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Central trial contact

Chak Yu Kent So

Data sourced from clinicaltrials.gov

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