| CTRI Number |
CTRI/2025/11/097460 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A retrospective and prospective, observational, multicenter registry study collecting medical records’ data from patients who have undergone, are undergoing or will undergo a transcatheter mitral/tricuspid ViV/ViR procedure, to find out the safety and efficacy of the procedures. |
|
Scientific Title of Study
|
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry. |
| Trial Acronym |
AP ViV Registry |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AP ViV Protocol V1.1 06 May 2025 |
Protocol Number |
| NCT07058935 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit MullasariS |
| Designation |
Chairman-HOD Cardiology |
| Affiliation |
The Madras Medical Mission |
| Address |
Clinical research, T. Block, 4 th floor no. 4A, dr. J.J nagar, Mogappair
Chennai
TAMIL NADU
600037
India |
| Phone |
914426565961 |
| Fax |
|
| Email |
icvddoctors@mmm.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kuldeep Patil |
| Designation |
Senior Director,Project Delivery |
| Affiliation |
Emerald Clinical Trials India Private Limited |
| Address |
Plot No. 5, Prestige Khoday Towers, 12th Floor, Raj Bhavan Road
Bangalore
KARNATAKA
560 001
India |
| Phone |
919975476427 |
| Fax |
|
| Email |
kpatil@emeraldclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Kuldeep Patil |
| Designation |
Senior Director,Project Delivery |
| Affiliation |
Emerald Clinical Trials India Private Limited |
| Address |
Plot No. 5, Prestige Khoday Towers, 12th Floor, Raj Bhavan Road
Bangalore
KARNATAKA
560 001
India |
| Phone |
919975476427 |
| Fax |
|
| Email |
kpatil@emeraldclinical.com |
|
|
Source of Monetary or Material Support
|
| National Heart Centre of Singapore 5 Hospital Drive
Singapore 169609 |
|
|
Primary Sponsor
|
| Name |
National Heart Centre Singapore (NHCS) |
| Address |
5 Hospital Drive
Singapore 169609 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Hong Kong
India
New Zealand
Thailand
Singapore |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AB Gopalamurugan |
MGM Healthcare Pvt Ltd |
No. 54, Clinical research Room no: 121, 1st floor, old 72, Nelson Manickam Rd, Aminjikarai 600029
Chennai
TAMIL NADU |
919962417118
heart@gopalamurugan.com |
| Dr Ajit Mullasari S |
The Madras Medical Mission |
Clinical research, T. Block, 4 th floor no. 4A, dr. J.J nagar, Mogappair 600037
Chennai
TAMIL NADU |
4426565961
icvddoctors@mmm.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - The Madras Medical Mission |
Approved |
| MGM- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age equal to or more than 21
2. Had at least one documented Mitral valve-in-valve or 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 or valve-in-ring procedure. (Prospective)
OR
Had at least one documented Tricuspid valve-in-valve or 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 or valve-in-ring procedure. (Prospective) |
|
| ExclusionCriteria |
| Details |
1. Active endocarditis
2. Any other conditions which investigator deems unsuitable for participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All-cause mortality |
Ongoing up to 13 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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) |
Ongoing up to 13 years |
| Procedural or In-hospital complications |
Ongoing up to 13 years |
| Major adverse cardiovascular events (Cardiovascualr mortality, Myocardial Infraction, stroke,etc) |
Ongoing up to 13 years |
| The New York Heart Association (NYHA) class |
Ongoing up to 13 years |
| Echocardiographic variables |
Ongoing up to 13 years |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
29/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="13"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral or tricuspid ViV or ViR procedure with balloon expandable valve.The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery.So hence, since the data on this therapy is particularly lacking in the Asia-Pacific region, especially importantly in the light of known differences in body habitus and size- the main aim of the study is to: Describe the real-world use of transcatheter mitral or tricuspid ViV/ViR in Asia-Pacific, determine predictors of procedural success, determine predictors of major procedural complications and to evaluate short or intermediate or long term safety and efficacy outcomes and its determinants.Data related to patient’s procedure will be collected and stored at the National Heart Centre Singapore (NHCS). Statistical analyses will be conducted using Stata version 16. |