Micra Asia Pacific Population Cohort Study
- Conditions
- Other disorder of circulatory system,
- Registration Number
- CTRI/2024/02/062775
- Lead Sponsor
- India Medtronic Pvt. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
- 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 To estimate the acute major complication rate related to the Micra System and/or the Micra system implant procedure. Baseline Follow up, Implant/ Procedure Follow up, 30 Days and 12 month follow up 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 Measures
Name Time Method 1 Implant/12-month electrical summary 2 Characterization of the implant procedure, anticoagulation strategy (Prior, during & after) procedure.
Trial Locations
- Locations (3)
M S Ramaiah Medical College and Hospitals
🇮🇳Bangalore, KARNATAKA, India
Max Super Specialty Hospital
🇮🇳Delhi, DELHI, India
Medanta – The Medicity
🇮🇳Gurgaon, HARYANA, India
M S Ramaiah Medical College and Hospitals🇮🇳Bangalore, KARNATAKA, IndiaDr VS PrakashPrincipal investigator9844033964drprakashvs@gmail.com