Valve Disease, HeartNCT07058935
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
An observational study of Valve Disease, Heart, run by National Heart Centre Singapore at 8 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Valve Disease, Heart
- How many people
- 150 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 17 Mar 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
Prince of Wales Hospital
Hong Kong
Clinical Research Coordinator, +852-35052211, danielxu@cuhk.edu.hk
Dr Kent So Chak Yu
- Not yet recruiting
Queen Elizabeth Hospital
Hong Kong
Clinical Research Coordinator, +852-35061088, lois.qeh@gmail.com
Dr Angus Chui Shing Fung
India2 sites, 2 recruiting
- Not yet recruiting
MGM Healthcare Pvt Ltd
Chennai, Tamil Nadu
Clinical Research Coordinator, 9677178012, secretary@gopalamurugan.com
Dr AB Gopalamurugan
- Not yet recruiting
The Madras Medical Mission
Chennai, Tamil Nadu
Clinical Research Coordinator, 9940484306, clireco@mmm.org.in
Dr Ajit Mullasari
Australia1 site, 1 recruiting
- Not yet recruiting
John Hunter Hospital
New Lambton Heights
Clinical Research Coordinator, 02 4985 5433, Anne.Gordon@health.nsw.gov.au
Dr Rohan Bhagwandeen
New Zealand1 site, 1 recruiting
- Not yet recruiting
Waikato Hospital
Hamilton
Clinical Research Coordinator, +64 7 839 7136, simi.christudasjayakumari@waikatodhb.health.nz
Dr Faeez Mohamad Ali
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore
Clinical Research Coordinator, +65-7042274, lim.yu.fei@nhcs.com.sg
A/Prof Jonathan Yap
Thailand1 site, 1 recruiting
- Not yet recruiting
Ramathibodi Hospital
Bangkok
Clinical Research Coordinator, +66819068607, Pachpan@hotmail.com
Dr Mann Chandavimol
About this study
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.
- Conditions
- Valve Disease, Heart
- Medical subject headings
- Heart Valve Diseases
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 |
|---|---|---|
| Mitral Valve-in-Valve | Patients who have undergone or will undergo a transcatheter mitral valve-in-valve procedure. | |
| Mitral Valve-in-Ring | Patients who have undergone or will undergo a transcatheter mitral valve-in-ring procedure. | |
| Tricuspid Valve-in-Valve | Patients who have undergone or will undergo a transcatheter tricuspid valve-in-valve procedure. | |
| Tricuspid Valve-in-Ring | Patients who have undergone or will undergo a transcatheter tricuspid valve-in-ring procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: From date of procedure to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start17 Mar 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Disease, HeartStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058935
- Sponsor's protocol ID
- 2024-4264
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
- ClinicalTrials.gov ID
- NCT07058935
- Acronym / sponsor ID
- 2024-4264
- Conditions
- Valve Disease, Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve-in-Valve | – | –Patients who have undergone or will undergo a transcatheter mitral valve-in-valve procedure. |
| Mitral Valve-in-Ring | – | –Patients who have undergone or will undergo a transcatheter mitral valve-in-ring procedure. |
| Tricuspid Valve-in-Valve | – | –Patients who have undergone or will undergo a transcatheter tricuspid valve-in-valve procedure. |
| Tricuspid Valve-in-Ring | – | –Patients who have undergone or will undergo a transcatheter tricuspid valve-in-ring procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Active endocarditis
- Any other conditions which investigator deems unsuitable for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: From date of procedure to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Valve Disease, Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Disease, Heart, run by National Heart Centre Singapore at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hong Kong, India, Australia, New Zealand, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Yip (+65-67042301, deborah.yip.x.y@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: From date of procedure to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.