| CTRI Number |
CTRI/2025/02/080986 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to check how safe and effective Triumvir, a dry transcatheter aortic valve replacement, is for patients who need a new aortic heart valve. |
|
Scientific Title of Study
|
A prospective, multi-centre, single arm, pivotal clinical study to determine the safety and effectiveness of Triumvir (Dry Transcatheter Aortic Valve Replacement) for use as a Replacement Aortic Heart Valve. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-DRY-TAVR-2024 version 1.0 dated 23-Aug-2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rajpal Kanaklal Abhaichand |
| Designation |
Principal Investigator |
| Affiliation |
G. Kuppuswamy Naidu Memorial Hospital, Coimbatore |
| Address |
G. Kuppuswamy Naidu Memorial Hospital, Clinical research department, room no 01, Netaji Rd, Pappanaickenpalayam, Coimbatore, Tamil Nadu 641037, India
Coimbatore
TAMIL NADU
641037
India |
| Phone |
9443272172 |
| Fax |
|
| Email |
rka.trials@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajpal Kanaklal Abhaichand |
| Designation |
Principal Investigator |
| Affiliation |
G. Kuppuswamy Naidu Memorial Hospital, Coimbatore |
| Address |
G. Kuppuswamy Naidu Memorial Hospital, Clinical research department, room no 01, Netaji Rd, Pappanaickenpalayam, Coimbatore, Tamil Nadu 641037, India
Coimbatore
TAMIL NADU
641037
India |
| Phone |
9443272172 |
| Fax |
|
| Email |
rka.trials@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
Chief Executive Officer |
| Affiliation |
CliniExperts Research Services |
| Address |
Plot No. 5, Unit No. 325, City Centre Mall, Sector 12 Dwarka, Dwarka, New Delhi, Delhi 110075
New Delhi
DELHI
110075
India
New Delhi
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Onecrea Medical India Pvt Ltd. No.326 2nd Floor, 9th Cross, 4th phase, P.I.A, Bangalore North, Bangalore - 560 068,
Karnataka |
|
|
Primary Sponsor
|
| Name |
Onecrea Medical India Pvt Ltd. |
| Address |
Onecrea Medical India Pvt Ltd.,No. 326 2nd Floor, 9th Cross, 4th phase, P.I.A, Bangalore North, Bangalore - 560 058,Karnataka |
| Type of Sponsor |
Other [Other [Medical Device Company]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajpal Kanaklal Abhaichand |
G. Kuppuswamy Naidu Memorial Hospital |
G. Kuppuswamy Naidu Memorial Hospital, Clinical research department, room no 01, Netaji Rd, Pappanaickenpalayam, Coimbatore, Tamil Nadu 641037, India
Coimbatore
TAMIL NADU |
9443272172
rka.trials@gmail.com |
| Dr Santosh Kumar Sinha |
LPS Institute of Cardiology & Cardiac Surgery |
Room NO. 13, 3rd Floor, LPS Institute of Cardiology & Cardiac SurgRoad, Rawatpur,Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH |
9670220088
fionasan@rediffmail.com |
| Dr Pravin K Goel |
Medanta Super Speciality Hospital |
Medanta Super Speciality Hospital, 1st floor, Clinical research room, Sector - A, Pocket - 1, Amar Shaheed Path, Golf City, Lucknow, Uttar Pradesh 226030, India
Lucknow
UTTAR PRADESH |
9839015010
golf-pgi@yahoo.co.in |
| Dr K Jai Shankar |
Medway Heart Institute, Chennai |
9, 1st Main Rd, United India Colony, Kodambakkam, Chennai, Tamil Nadu 600024
Chennai
TAMIL NADU |
9791044123
drkjs68@gmail.com |
| Dr Ranjan Shetty K |
Sparsh Group of Hospitals |
146 Infantry Road Opposite to police Commissioners Office, Bangalore-560001, India
Bangalore
KARNATAKA |
9243350978
ranjan.shetty@gmail.com |
| Dr Deepak Basia |
Subharti Medical College And Hospital |
Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut, Uttar Pradesh-250005, India
Meerut
UTTAR PRADESH |
8601168861
deepakbasia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| IEC LPS Institute of Cardiology |
Approved |
| Institutional Ethics Committee Medanta Lucknow |
Submittted/Under Review |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
| Institutional Ethics Committee Subharti Medical College And Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, GKNM HOSPITAL |
Approved |
| Institutional Ethics Committee-Medway Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Triumvir (Dry Transcatheter Aortic Valve Replacement) |
Triumvir (Dry Transcatheter Aortic Valve Replacement)
Frequency-Once, Duration-Lifetime |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female at least 18 years of age.
2. Patient provides written informed consent and agrees to all follow-up visits.
3. Patients life expectancy at least 1 year.
4. subjects with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure who are judged by a heart team, including a cardiac surgeon, to be at high or high risk for open surgical therapy.
5. Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use.
6. Bicuspid aortic valve can be included at the discretion of the Physician team |
|
| ExclusionCriteria |
| Details |
1. Patients with Mechanical valve in the aortic position.
2. Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated.
3. Known allergy to any device component.
4. Ongoing sepsis, including active endocarditis
5. Pregnant (female of childbearing potential only).
6. Patient with Ejection Fraction of less than 35%.
7. Patient expected to undergo for coronary intervention within 12 Months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety Endpoint is evaluated by
1. All-cause mortality
2. Valve-related morbidity [stroke and transient ischemic attack
(TIA)
3. Major and minor bleeding
4. Acute kidney injury (AKI)
5. Valve thrombosis.
6. Structural/non-structural valve deterioration or dysfunction
7. Prosthetic valve endocarditis
8. Myocardial infarction
9. Conduction disturbances and arrhythmias
10. Aortic valve apparatus damage or dysfunction
11. Explant
12. Hemolysis
|
baseline, procedure, discharge, 1 month, 3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Secondary study endpoints are:
Device success
Procedural success
Quality of life |
baseline, procedure, discharge, 1 month, 3 months, 6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/03/2025 |
| 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="1"
Months="8"
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
|
To evaluate safety and performance outcomes following treatment with the study device in subjects at high surgical risk, as determined by the heart team who require replacement of their native aortic valve due to symptomatic, severe, aortic valve stenosis (AS). High surgical risk is defined as predicted risk of surgical mortality 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator. The total planned study duration is 20 months, which includes an initial recruitment period of 6 months and follow-up period of 12 months and 02-months time for post study analysis and site close outs. However, if the planned recruitment is not completed within the initial 6 months, the recruitment period will be prolonged until the planned recruitment is completed. |