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

Active, not recruiting

• Conditions: Ventricular Tachycardia

• Registration Number: NCT04496518
• Lead Sponsor: Medtronic

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study Start: 2020-08-01
• Study First Posted: 2020-08-03
• Status Verified: 2024-06
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-05-12
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2200

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

Exclusion Criteria

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%	Approximately 5 years	Demonstrating success rate of iATP

Secondary Outcome Measures

Name	Time	Method
To characterize arrhythmia-related syncope events	Approximately 5 years	characterizing arrhythmia-related syncope events
To demonstrate the success rate of iATP in the FVT zone is greater than 70%	Approximately 5 years	Demonstrating success rate of iATP
To characterize unnecessary and inappropriate shocks	Approximately 5 years	characterizing unnecessary and inappropriate shocks

Trial Locations

Locations (92)

Norton Heart and Vascular Institute; 🇺🇸 Louisville, Kentucky, United States

Southwest EP; 🇺🇸 Chandler, Arizona, United States

Saint Vincent Heart Clinic Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Chula Vista Cardiac Center; 🇺🇸 Chula Vista, California, United States

Cardiovascular Consultants Medical Group (Van Nuys CA); 🇺🇸 Van Nuys, California, United States

Cardiology Associates Medical Group; 🇺🇸 Ventura, California, United States

Colorado Springs Cardiology; 🇺🇸 Colorado Springs, Colorado, United States

Denver Heart; 🇺🇸 Denver, Colorado, United States

Colorado Heart and Vascular, PC; 🇺🇸 Lakewood, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

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