| CTRI Number |
CTRI/2024/02/062775 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Micra Asia Pacific Population Cohort Study |
|
Scientific Title of Study
|
Cardiac Rhythm and Heart Failure PRODUCT SURVEILLANCE REGISTRY {PSR) PLATFORM
BASE, Product Surveillance Registry {PSR) Miera All-Comers Regional Evidence Appendix {AREA)
{PSR Miera AREA) Study. |
| Trial Acronym |
CRHF Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Director Clinical and Medical Affairs, India and Southeast Asia |
| 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)
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Director Clinical and Medical Affairs, India and Southeast Asia |
| 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)
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay Rajan |
| Designation |
Director Clinical and Medical Affairs, India and Southeast Asia |
| 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)
MAHARASHTRA
400093
India |
| Phone |
|
| 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
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VS Prakash |
M S Ramaiah Medical College and Hospitals |
Room no: 16, Department of Cardiology, Division of Interventional Cardiology, First Floor, MS Ramaiah Advanced Learning Center,
M S Ramaiah Nagar, MSRIT Post, Bangalore – 560054 (India)
Bangalore
KARNATAKA |
9844033964
drprakashvs@gmail.com |
| Dr Balbir Singh |
Max Super Specialty Hospital |
Room no: 6, Department of Cardiology, Division of Interventional Cardiology, 2, Press Enclave Road,
Saket New Delhi – 110017, India.
New Delhi
DELHI |
9310015172
drbalbirs@gmail.com |
| Dr Praveen Chandra |
Medanta – The Medicity |
Room no: , Department of Cardiology, Division of Interventional Cardiology, CH Baktawar Singh Rd, near Olympus, Medicity,
Medicity, Islampur Colony, Sector 38
Gurugram, Haryana- 122001. India.
Gurgaon
HARYANA |
9811833332
praveen.chandra@medanta.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, MS RamaiahMedical College and Hospital |
Approved |
| Institutional Ethics Committee - Devki Devi Foundation |
Approved |
| Institutional Ethics Committee Apollo Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee Aster Medcity |
Submittted/Under Review |
| Institutional Ethics Committee Eternal Hospital |
Submittted/Under Review |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
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 prior to the implant procedure |
|
| 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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To estimate the acute major complication rate related to the Micra System and/or the Micra system implant procedure.
2 To estimate the 12 months chronic major complication rate related to the Micra System and/or implant procedure. |
Baseline Follow up, Implant/ Procedure Follow up, 30 Days and 12 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Implant/12-month electrical summary
2 Characterization of the implant procedure, anticoagulation strategy (Prior, during & after) procedure.
3 Characterization of patient profiles |
Baseline Follow up, Implant/ Procedure Follow up, 30 Days & 12 month follow up |
|
|
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)
|
01/03/2024 |
| 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="3"
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
|
The purpose of the PSR is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use. PSR data will support post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests. The PSR will also obtain clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research. |