Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

Recruiting in Palo Alto (17 mi)

+142 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic

No Placebo Group

Trial Summary

What is the purpose of this trial?

Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices. The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).

Research Team

Eligibility Criteria

Inclusion Criteria

Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Patient is intended to receive or is implanted with an iATP-capable device with iATP on in any zone with ventricular ATP therapies programmed.

Patient is enrolled in the CareLink network for remote device monitoring

Treatment Details

Interventions

Intrinsic Antitachycardia Pacing (iATP) Therapy (Device)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Patients with ICD/CRT device with iATP programmed onExperimental Treatment1 Intervention

Patients implanted with an iATP-capable device with iATP on in at least one device detection zone will be enrolled in the iATP PAS. Patients must also be enrolled in the CareLink network for remote monitoring. All patients must have provided signed informed consent.