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

NCT ID: NCT07296016

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-05

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Structural Heart Disease Mitral Valve Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prospective

Patient planned to undergo a Mitral valve-in-valve/valve-in-ring procedure.

No interventions assigned to this group

Retrospective

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart Centre Singapore

OTHER

Sponsor Role collaborator

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr So Chak Yu kent

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Chak Yu Kent So

Role: CONTACT

Phone: 852-35051518

Email: [email protected]

Other Identifiers

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2025.502

Identifier Type: -

Identifier Source: org_study_id