| CTRI Number |
CTRI/2025/08/092807 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
TriageHF India Study |
|
Scientific Title of Study
|
Cardiac Rhythm and Heart Failure Product Surveillance Registry (PSR) Platform Base - Triage HF India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd. Solitaire Corporate Park, Bldg No. 12, 6th Floor Andheri Ghatkopar Link Road, Andheri (E) Mumbai, Maharashtra - 400093 Mumbai (Suburban)
India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02248810700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd. Solitaire Corporate Park, Bldg No. 12, 6th Floor Andheri Ghatkopar Link Road, Andheri (E) Mumbai, Maharashtra - 400093 Mumbai (Suburban)
India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02248810700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd. Solitaire Corporate Park, Bldg No. 12, 6th Floor Andheri Ghatkopar Link Road, Andheri (E) Mumbai, Maharashtra - 400093 Mumbai (Suburban)
India
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02248810700 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt Ltd Solitaire Corporate Park, Bldg No. 12, 6th Floor Andheri Ghatkopar Link
Road, Andheri (e) Mumbai, Maharashtra - 400093 |
|
|
Primary Sponsor
|
| Name |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd Solitaire Corporate Park, Bldg No. 12, 6th Floor Andheri Ghatkopar Link
Road, Andheri (e) Mumbai, Maharashtra - 400093 |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narasimhan Calambur |
AIG HOSPITAL |
AIG HOSPITAL #No 136, Plot No 2/3/4/5 Survey,
1, Mindspace Road,
Gachibowli, Hyderabad,
Telangana 500032 India.
Hyderabad
TELANGANA |
9848052409
calambur1@gmail.com |
| Dr A M KARTHIGESAN |
Apollo Hospitals |
Apollo Research & Innovation, kridhnadeep chambers,#1 wallance garden,Thousand light, Chennai - 600006, India
Chennai
TAMIL NADU |
9498335400
drkarthigesan_am@apollohospitals.com |
| Dr Girish B Navasundi |
Apollo Hospitals |
Apollo Hospitals, Bengaluru, having its 154/11, Opposite. I.I.M., Bannerghatta Road ,Bengaluru, 560076, Karnataka, India
Bangalore
KARNATAKA |
9611099226
navasundi@rediffmail.com |
| Dr Santosh Dora |
Asian Heart Hospital |
G/N Block, Bandra Kurla Complex, Bandra (E), Mumbai 400051
Mumbai
MAHARASHTRA |
9920069719
santosh.dora@ahirc.com |
| Dr Praveen Sreekumar |
Aster Medicity Hospital |
Aster Medicity Hospital,
Kuttisahib Road, Cheranalloor Kochi - 682027, Kerala, India
Ernakulam
KERALA |
9995805278
preveen_sreekumar2004@yahoo.com |
| Dr Anil Saxena |
Fortis Escorts Heart Institute |
Fortis Escorts Heart Institute,Metro Station, Okhla Rd,
Jamia Millia Islamia, Sukhdev Vihar,Okhla, New Delhi, Delhi 110025
New Delhi
DELHI |
9810025511
anil.saxena@hotmail.com |
| Dr Deep Chandh Raja S |
Kauvery Hospital |
Kauvery Hospital, No.199, Luz Church Road, Mylapore
Chennai
TAMIL NADU |
9043632236
deepchandh@gmail.com |
| Dr Dilip Kumar |
Manipal Hospitals Eastern India Pvt. Ltd |
127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099, India
Kolkata
WEST BENGAL |
9748487563
dilipcardio@gmail.com |
| Dr Ajay Naik |
Marengo CIMS Hospital |
Marengo CIMS Hospital
Science City Road, Sola,
Ahmedabad, Gujarat 380060
Ahmadabad
GUJARAT |
9825082666
ajay.naik@cims.me |
| Dr Kartikeya Bhargava |
Medanta – The Medicity Hospital |
Medanta – The Medicity
Sector 38, Gurugram
Haryana - 122001
Gurgaon
HARYANA |
1244141414
kartikeya.bhargava@medanta.org |
| Dr Rajesh Vijayvergiya |
Post Graduate Institute of Medical Education & Research |
PGIMER, Department of Cardiology, Madhya Marg, Sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH |
7696067448
rajeshvijay999@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aster Medcity |
Approved |
| Institutional Ethics Committee Sri Kauvery Medical Care |
Not Applicable |
| Institutional Ethics Committee - Bio Medical Research |
Approved |
| Institutional Ethics Committee Asian Heart Institute |
Submittted/Under Review |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Submittted/Under Review |
| Institutional Ethics Committee Fortis Escorts Heart Institute |
Submittted/Under Review |
| Institutional Ethics Committee Madras Medical Mission |
Submittted/Under Review |
| Institutional Ethics Committee Marengo Asia Healthcare Private Limited |
Approved |
| Institutional Ethics Committee Medanta The Medicity |
Submittted/Under Review |
| Institutional Ethics Committee Medica Sperspeciality Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Post Graduate Institute of Medical Education and Research |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
2. Patient has, or is intended to receive or be treated with, an eligible Medtronic product
3. Patient is consented within the enrollment window of the therapy received, as applicable
4. Additional Therapy-specific components if needed |
|
| ExclusionCriteria |
| Details |
1. Patient who is, or is expected to be, inaccessible for follow-up
2. Participation is excluded by local law
3. Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
4. Additional Therapy-specific components if needed |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. All data collected from regional cohorts will contribute to the overall primary objective of safety and effectiveness of the product
2. The primary effectiveness objective is to estimate the positive predictive value (PPV) of HFRS high risk status associated with worsening heart failure. |
Baseline, Implant/ Procedure, 12 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Summarize the number of subsequent heart failure hospitalization (HFH) or HF related deaths that were not preceded by a high Heart Failure Risk Status.
2. Compare the incidence in subsequent heart failure hospitalization between subjects with actions taken based on HFRS and subjects without actions taken.
|
Baseline, Implant/ Procedure, 12 months follow up |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="2"
Months="0"
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
|
This is a non-randomized, prospective and non-regulated study on commercial released TraigeHF which is enabled with Cobalt/Crome device. The main objective of study is to collect data from regional cohorts and assess the overall primary objective of safety and effectiveness of the commercialized product. Study will be conducted in 10-12 sites in India with a target to enroll 100 patients. Study duration will be 2-3 years which include 12 months follow up. Data will be collected at Baseline (consenting, eligibility, pre-procedure and Medical history), CVG procedure (Procedure type and implant) and follow-up visits. |