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

NCT04496518 · tracked via the Priya Life Science USA tracker

Sponsor

Medtronic

Phase

Observational

Started

2020-08-01

Last updated

2025-10-20

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

Intrinsic Antitachycardia Pacing (iATP) Therapy

Intrinsic Antitachycardia Pacing (iATP) Therapy: iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

Study 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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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

Trial sites (92)

Facility	City	Region
Southwest EP	Chandler	Arizona
Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
Chula Vista Cardiac Center	Chula Vista	California
Cardiovascular Consultants Medical Group (Van Nuys CA)	Van Nuys	California
Cardiology Associates Medical Group	Ventura	California
Colorado Springs Cardiology	Colorado Springs	Colorado
Denver Heart	Denver	Colorado
Colorado Heart and Vascular, PC	Lakewood	Colorado
Hartford Hospital	Hartford	Connecticut
Yale New Haven Hospital	New Haven	Connecticut
Heart Rhythm Solutions	Hollywood	Florida
Baptist Health	Jacksonville	Florida
Cardiovascular Institute of Northwest Florida	Panama City	Florida
Heart & Vascular Institute of Florida	Safety Harbor	Florida
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)	Sarasota	Florida
Deaconess Specialty Physicians	Evansville	Indiana
Iowa Heart Center (West Des Moines IA)	Des Moines	Iowa
The University of Kansas Medical Center	Kansas City	Kansas
Norton Heart and Vascular Institute	Louisville	Kentucky
Tidal Health Peninsula Regional	Salisbury	Maryland
Associates in Cardiology PA	Silver Spring	Maryland
Brigham and Women's Hospital (Boston MA)	Boston	Massachusetts
Sparrow Clinical Research Institute	Lansing	Michigan
Michigan Heart	Ypsilanti	Michigan
Mayo Clinic (Rochester MN)	Rochester	Minnesota
Missouri Cardiovascular Specialists	Columbia	Missouri
University Hospital (Columbia MO)	Columbia	Missouri
Saint Lukes Health System	Kansas City	Missouri
Washington University School of Medicine	St Louis	Missouri
Nebraska Medicine	Omaha	Nebraska
Monmouth Cardiology Associates	Ocean City	New Jersey
Presbyterian Heart Group	Albuquerque	New Mexico
South Shore University Hospital	Bay Shore	New York
Huntington Hospital	Huntington	New York
North Shore University Hospital	Manhasset	New York
Northern Westchester Hospital	Mount Kisco	New York
Long Island Jewish Medical Center	New Hyde Park	New York
New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
NewYork-Presbyterian/Columbia University Irving Medical Center	New York	New York
Lenox Hill Hospital	New York	New York

+ 52 more sites — see the full list on the official registry below.

More Medtronic trials in the USA

Personalized Therapy Study - Attain Stability Quad Post-Approval Study Active, not recruiting

Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting

Micra Transcatheter Pacing System Post-Approval Registry Active, not recruiting

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy Recruiting

Other trials for the same condition

Abbott Ventricular Tachycardia PAS Active, not recruiting

Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT) Recruiting

Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04496518 on ClinicalTrials.gov ↗ ← All trials in the USA