Structural Heart DiseaseAP ViVNCT07296016
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry
An observational study of Structural Heart Disease and Mitral Valve Regurgitation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Structural Heart Disease, Mitral Valve Regurgitation
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jun 2026to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Active endocarditis
- Any other conditions which investigator deems unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Shatin, 0000
Chak Yu So, 85235051518, scy309@ha.org.hk
About this study
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.
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Rate of All-cause mortality in enrolled patients
Measured: 10 years
Secondary outcomes (5)
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)
Measured: 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)
Measured: Periprocedural
Major adverse cardiovascular events rate
Rate of Major adverse cardiovascular events in enrolled patients
Measured: 10 years
New York Heart Association (NYHA) classification
NYHA class of enrolled patients
Measured: 10 years
Echocardiographic result
Rate of Major adverse cardiovascular events in enrolled patients
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start29 Jun 2026
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Centre Singapore
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296016
- Sponsor's protocol ID
- 2025.502
- Acronym
- AP ViV
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No