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

October 16, 2025 updated by: Medtronic

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84082
        • Clinique Rhône Durance
      • Brest, France, 29609
        • CHU de Brest
      • Caen, France, 14000
        • Générale de Santé - Hôpital Privé Saint Martin
      • Caen, France, 14033
        • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand - Gabriel-Montpied
      • Dijon, France, 21079
        • CHU de Dijon - Hospital Le Bocage
      • La Rochelle, France, 17019
        • CHRU La Rochelle
      • Nantes, France, 44277
        • Nouvelles Cliniques Nantaises
      • Pringy, France, 74374
        • Centre hospitalier de la région d'Annecy
      • Saint-Priest-en-Jarez, France, 42270
        • Centre Hospitalier Universitaire Saint Etienne
      • Villeurbanne, France, 69100
        • Capio - Clinique du Tonkin
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Marousi, Greece, 15125
        • Athens Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant' Orsola - Malpighi
      • Castrovillari, Italy, 87012
        • Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"
      • Lecce, Italy, 73100
        • Ospedale "Vito Fazzi" Lecce
      • Milan, Italy, 20162
        • Azienda Ospedaliera ospedale Niguarada ca Granda
      • Taranto, Italy, 74024
        • Presidio Ospedaliero Centrale - SS.Annunziata
      • Udine, Italy, 33100
        • Azienda ospedaleria Santa Maria dellaMisericordia di Udine
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira -Guimarães
      • Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitário de SãoJoão Alameda
      • Santarém, Portugal, 2000-177
        • Hospital Distrital de Santarém
  • Slovakia
      • Bratislava, Slovakia
        • Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario da Coruña
      • Granda, Spain, 18014
        • Hospital Universitario Virgen De Las Nieves
      • Granda, Spain, 18016
        • Hospital Universitario Clínico San Cecilio
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Salamanca, Spain, 37007
        • Complejo Universitario de Salamanca
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Santiago, Spain, 15706
        • Complejo Hospitalario Universitario De Santiago De Compostela
      • Valladolid, Spain, 47006
        • Hospital Clínico Universitario de Valladolid
  • Switzerland
      • Geneva, Switzerland, 1205
        • Hôpitaux Universitaires de Genève
      • Zurich, Switzerland, 8027
        • Cardiopark Zurich
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust Hammersmith Hospital
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS - mancester Royal Infirmary
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital - SouthTees Hospitals NHS
      • Sheffield, United Kingdom, S5 7AU
        • Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Southwest EP
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-6202
        • Saint Vincent Heart Clinic Arkansas
    • California
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • Van Nuys, California, United States, 91405
        • Cardiovascular Consultants Medical Group (Van Nuys CA)
      • Ventura, California, United States, 93003
        • Cardiology Associates Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Cardiology
      • Denver, Colorado, United States, 80220
        • Denver Heart
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular, PC
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Florida
      • Hollywood, Florida, United States, 33021-3552
        • Heart Rhythm Solutions
      • Jacksonville, Florida, United States, 32207-8208
        • Baptist Health
      • Panama City, Florida, United States, 32405
        • Cardiovascular Institute of Northwest Florida
      • Safety Harbor, Florida, United States, 34695-6604
        • Heart & Vascular Institute of Florida
      • Sarasota, Florida, United States, 34233
        • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Deaconess Specialty Physicians
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart Center (West Des Moines IA)
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • The University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Norton Heart and Vascular Institute
    • Maryland
      • Salisbury, Maryland, United States, 21801
        • Tidal Health Peninsula Regional
      • Silver Spring, Maryland, United States, 20910-1265
        • Associates in Cardiology PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-6110
        • Brigham and Women's Hospital (Boston MA)
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Ypsilanti, Michigan, United States, 48197-8633
        • Michigan Heart
    • Minnesota
      • Rochester, Minnesota, United States, 55902-1906
        • Mayo Clinic (Rochester MN)
    • Missouri
      • Columbia, Missouri, United States, 65201-8023
        • Missouri Cardiovascular Specialists
      • Columbia, Missouri, United States, 65201
        • University Hospital (Columbia MO)
      • Kansas City, Missouri, United States, 64111-5934
        • Saint Lukes Health System
      • St Louis, Missouri, United States, 63110-1010
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Nebraska Medicine
    • New Jersey
      • Ocean City, New Jersey, United States, 07712-4764
        • Monmouth Cardiology Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4921
        • Presbyterian Heart Group
    • New York
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital
      • Huntington, New York, United States, 11743
        • Huntington Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10021
        • New York-Presbyterian Hospital/Weill Cornell Medical Center
      • New York, New York, United States, 10032
        • NewYork-Presbyterian/Columbia University Irving Medical Center
      • Poughkeepsie, New York, United States, 12601-3923
        • Hudson Valley Heart Center
      • Staten Island, New York, United States, 10305-3436
        • Staten Island University Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Akron, Ohio, United States, 44304-1473
        • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
      • Cincinati, Ohio, United States, 45219
        • The Christ Hospital Health Network
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015-1000
        • St Luke's University Health Network
    • Tennessee
      • Nashville, Tennessee, United States, 37205-2018
        • Saint Thomas Research Institute
    • Texas
      • Austin, Texas, United States, 78705-1852
        • Texas Cardiac Arrhythmia Research Foundation
      • Fort Worth, Texas, United States, 761014
        • Heart Center of North Texas
      • Fort Worth, Texas, United States, 76104
        • Consultants in Cardiology (Fort Worth TX)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215-3678
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients providing informed consent to participate prior to or within 30 days of implant of an iATP-capable cardiac rhythm device with iATP on in at least one zone. Patients need to be enrolled in Medtronic's CareLink network for remote device monitoring.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with ICD/CRT device with iATP programmed on
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.
Device: Intrinsic Antitachycardia Pacing (iATP) Therapy
iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%
Time Frame: Approximately 5 years
Demonstrating success rate of iATP
Approximately 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

November 6, 2024

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iATP PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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