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

NCT07296016 | Not Yet Recruiting DMC

• 1 other identifier: 2025.502
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Structural Heart Disease; Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Rate of All-cause mortality in enrolled patients

  10 years

Secondary Outcomes (5)

• Procedural technical success rate

  Immediately after operation

• Procedural complication rate

  Periprocedural

• Major adverse cardiovascular events rate

  10 years

• New York Heart Association (NYHA) classification

  10 years

• Echocardiographic result

  10 years

Study Arms (2)

Prospective

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

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is 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 from 1 Jan 2023 to 31 Dec 2035.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead
• National Heart Centre Singapore: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Chak Yu Kent So

CONTACT

852-35051518; scy309@ha.org.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 22, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)