NCT04496518

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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).

Detailed description

The iATP PAS is a global, prospective, observational, multi-site registry study. Patients enrolled in the iATP PAS will be prospectively followed in the registry until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent). Patient and device status will be assessed at least annually or as prompted by reportable adverse events. Remote device data transmissions are recommended to occur at least quarterly. Primary objective analysis will occur when 241 iATP-treated eligible ventricular episodes in the fast ventricular tachycardia (FVT) zone have been collected and reviewed by the study episode review committee (ERC). The total study duration is approximately 5 years.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Intrinsic Antitachycardia Pacing (iATP) Therapy	iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-11-06
• Completion: 2028-01-31
• First posted: 2020-08-03
• Last updated: 2025-10-20

Locations

92 sites across 9 countries: United States, France, Greece, Italy, Portugal, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study