Health Condition 1: I499- Cardiac arrhythmia, unspecified
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
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 within the enrollment window of the therapy received, as applicable 4. Additional Therapy-specific components if needed
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 4. Additional Therapy-specific components if needed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Baseline, Implant/ Procedure, 12 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Baseline, Implant/ Procedure, 12 months follow up | — |
Countries
India
Contacts
Public ContactVinay Rajan
India Medtronic Pvt Ltd
Outcome results
None listed