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NCT Number: NCT07296016

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

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.

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Key information

Conditions

Structural Heart Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Mitral Valve Regurgitation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong, Shatin, 0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 10 years

    Rate of All-cause mortality in enrolled patients

Secondary outcomes

  1. Procedural technical success rate

    Time frame: Immediately after operation

    Rate of Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure)

  2. Procedural complication rate

    Time frame: Periprocedural

    Rate of Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure)

  3. Major adverse cardiovascular events rate

    Time frame: 10 years

    Rate of Major adverse cardiovascular events in enrolled patients

  4. New York Heart Association (NYHA) classification

    Time frame: 10 years

    NYHA class of enrolled patients

  5. Echocardiographic result

    Time frame: 10 years

    Rate of Major adverse cardiovascular events in enrolled patients

Study contacts

Contact information is provided by the study sponsor or research team.

Chak Yu Kent So

CONTACT

[email protected]

852-35051518

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Collaborators

  • National Heart Centre Singapore

Registry information

Acronym: AP ViV

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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