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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Valve Regurgitation; Structural Heart Disease

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Chak Yu Kent So; Phone Number: 852-35051518; Email: scy309@ha.org.hk

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong, 0000
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Rate of All-cause mortality in enrolled patients	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural technical success rate	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)	Immediately after operation
Procedural complication rate	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)	Periprocedural
Major adverse cardiovascular events rate	Rate of Major adverse cardiovascular events in enrolled patients	10 years
New York Heart Association (NYHA) classification	NYHA class of enrolled patients	10 years
Echocardiographic result	Rate of Major adverse cardiovascular events in enrolled patients	10 years

Collaborators and Investigators

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Collaborators: National Heart Centre Singapore

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2025.502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No