Health Condition 1: null- Patient group: â?¢ EF 30%, NYHA Class I, 40 days Post-MI â?¢ EF 35%, NYHA Class II/III, Ischemia/Non-Ischemia â?¢ EF 40%, NSVT, 40 days Post-MI
Conditions
Interventions
Intervention1: Market-Released Medtronic ICD or CRT-D Device & Medtronic CareLink® Monitor
and CareLink® Network: Subjects who enroll in the study and proceed with a device implant must be
implanted
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject has a Class I indication for implantation of an ICD according to the ACC/AHA/HRS or ESC Guidelines ï?· Subject (or subjectâ??s legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.
Exclusion criteria
Exclusion criteria: Subject is ï?· Subject with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding) ï?· Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader ï?· Subject has any contraindication for ICD/CRT-D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that appropriate VT/VF therapy rates (shock and ATP) for subjects meeting 1.5 prevention criteria implanted with a Medtronic device (ICD/CRT-D) are equivalent (within 30%) to rates in subjects meeting secondary prevention criteria.Timepoint: 12 month and 24 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the mortality rates for patients meeting 1.5 prevention criteria between those implanted with a device (ICD/CRT-D) and those not implantedTimepoint: Follow ups at every 6 - month after implant | — |
Countries
India
Contacts
Public ContactHaresh Sachanandani
India Medtronic Pvt. Ltd.
Outcome results
None listed