Cardiac Arrhythmias
Conditions
Interventions
None listed
Sponsors
Yamamoto Takuto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible Medtronic product Patient is consented within the enrollment window of the therapy received
Exclusion criteria
Exclusion criteria: Patient who is, or is expected to be, inaccessible for follow-up Participation is excluded by local law 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 |
|---|---|
| Characterize the freedom from major complications related to the Aurora EV-ICD System and/or procedure at 2-years post implant | — |
Secondary
| Measure | Time frame |
|---|---|
| - Estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant - Characterize the rate of abnormal battery depletion complications as a function of time post-implant - Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken - Summarize patient deaths - Summarize patient demographics and baseline medical history - Characterize extracardiac pacing sensation - Summarize ATP with spontaneous arrhythmias - Characterize asystole pacing - Characterize sensing and detection - Characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia | — |
Contacts
Public ContactTakuto Yamamoto
Medtronic Japan
Outcome results
None listed