Health Condition 1: I998- Other disorder of circulatory system
Conditions
Interventions
None listed
Sponsors
India Medtronic Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Baseline Follow up, Implant/ Procedure Follow up, 30 Days and 12 month follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Implant/12-month electrical summary 2 Characterization of the implant procedure, anticoagulation strategy (Prior, during & after) procedure. 3 Characterization of patient profilesTimepoint: Baseline Follow up, Implant/ Procedure Follow up, 30 Days & 12 month follow up | — |
Countries
India
Contacts
Public ContactVinay Rajan
India Medtronic Pvt Ltd
Outcome results
None listed