| CTRI Number |
CTRI/2025/09/094601 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post Market Clinical Follow-up Study of CardiaMed Prosthetic Heart Valve |
|
Scientific Title of Study
|
POST MARKET CLINICAL FOLLOW UP STUDY OF CARDIAMED PROSTHETIC HEART VALVE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Jadhav |
| Designation |
HOD and Professor , CVTS |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
305-CVTS office, ground floor CVTC building, Seth GS Medical College and KEM Hospital,Acharya Done Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8169026862 |
| Fax |
8169026862 |
| Email |
udayej@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Heli Oza |
| Designation |
Assistant Professor, CVTS |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
305-CVTS office, ground floor CVTC building, Seth GS Medical College and KEM Hospital,Acharya Done Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619381403 |
| Fax |
|
| Email |
heli1992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Heli Oza |
| Designation |
Assistant Professor, CVTS |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
305-CVTS office, ground floor CVTC building, Seth GS Medical College and KEM Hospital,Acharya Done Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619381403 |
| Fax |
|
| Email |
heli1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| TTK HEALTHCARE-No.6, Cathedral Road, Chennai 600 086Other [Medical Device Manufacturer] |
|
|
Primary Sponsor
|
| Name |
TTK HEALTHCARE LIMITED |
| Address |
No.6, Cathedral Road, Chennai 600 086 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Heli Oza |
kem hospital |
305-cvtc office,ground floor
Mumbai
MAHARASHTRA |
9619381403
heli1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC -KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing isolated valvular surgery. |
|
| ExclusionCriteria |
| Details |
Patients who have undergone any other type of open heart surgery along with valve will be excluded.
also ,if patients have died during this span post surgery are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The objective of this study is to assess continued safety and effectiveness of the
CardiaMed Prosthetic Heart Valve.
The ACCEPTANCE HYPOTHESIS is that the adverse events or true rate of complications
associated with the CardiaMed Prosthetic heart Valves are less than two times the
Objective Performance Criteria (OPCs) specified in the international standard ISO
5840-2:2021. |
The outcome is to look into the results post surgery at the end of 1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Rheumatic heart disease is a growing concern in India, which causes single or multiple valve stenosis and regurgitation. Patients eventually undergo open heart surgery for valve replacement using mechanical bileaflet prosthetic valve.This study is to study the long term effects of prosthetic valve in terms of anticoagulation doses and post op ECHO findings and NYHA class. |