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

Last updated: March 31, 2025
Sponsor: Medtronic
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

Intrinsic Antitachycardia Pacing (iATP) Therapy

Clinical Study ID

NCT04496518
iATP PAS
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

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

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

  • Patient is enrolled in the CareLink network for remote device monitoring

Exclusion

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/ordevice study that may confound results

Study Design

Total Participants: 2200
Treatment Group(s): 1
Primary Treatment: Intrinsic Antitachycardia Pacing (iATP) Therapy
Phase:
Study Start date:
August 01, 2020
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Clinique Rhône Durance

    Avignon, 84082
    France

    Site Not Available

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109
    France

    Site Not Available

  • CHU de Brest

    Brest, 29609
    France

    Site Not Available

  • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

    Caen, 14033
    France

    Site Not Available

  • Générale de Santé - Hôpital Privé Saint Martin

    Caen, 14000
    France

    Site Not Available

  • CHU Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • CHU de Dijon - Hospital Le Bocage

    Dijon, 21079
    France

    Site Not Available

  • CHRU La Rochelle

    La Rochelle, 17019
    France

    Site Not Available

  • Hopital prive Clairval - Ramsay Sante

    Marseille, 13009
    France

    Site Not Available

  • che da la region d'Annecy

    Metz-Tessy,
    France

    Site Not Available

  • Nouvelles Cliniques Nantaises

    Nantes, 44277
    France

    Site Not Available

  • Centre hospitalier de la région d'Annecy

    Pringy, 74374
    France

    Site Not Available

  • Centre Hospitalier Universitaire Saint Étienne

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • Capio - Clinique du Tonkin

    Villeurbanne, 69100
    France

    Site Not Available

  • Hygeia Hospital

    Athens, 15123
    Greece

    Site Not Available

  • Athens Medical Center

    Maroúsi, 15125
    Greece

    Site Not Available

  • Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari

    Bari,
    Italy

    Site Not Available

  • Policlinico Sant' Orsola - Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

    Castrovillari, 87012
    Italy

    Site Not Available

  • Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

    Cosenza,
    Italy

    Site Not Available

  • Ospedale "Vito Fazzi" Lecce

    Lecce, 73100
    Italy

    Site Not Available

  • Azienda Ospedaliera ospedale Niguarada ca Granda

    Milano, 20162
    Italy

    Site Not Available

  • Presidio Ospedaliero Centrale - SS.Annunziata

    Taranto, 74024
    Italy

    Site Not Available

  • Azienda ospedaleria Santa Maria dellaMisericordia di Udine

    Udine, 33100
    Italy

    Site Not Available

  • Hospital da Senhora da Oliveira -Guimarães

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE

    Lisbon, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário de SãoJoão Alameda

    Porto, 4200-319
    Portugal

    Site Not Available

  • Hospital Distrital de Santarém

    Santarém, 2000-177
    Portugal

    Site Not Available

  • Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

    Bratislava,
    Slovakia

    Site Not Available

  • Hospital Universitario da coruna

    Coruna, 15006
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granda, 18016
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granda, 18014
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario da coruna

    Saint-Sébastien,
    Spain

    Site Not Available

  • Complejo Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago, 15706
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Candelaria

    Tenerife, 38010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47006
    Spain

    Site Not Available

  • Kantonsspital Aarau

    Aarau, 5001
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Geneva, 1205
    Switzerland

    Site Not Available

  • Cardiopark Zurich

    Zürich, 8027
    Switzerland

    Site Not Available

  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital

    Blackpool, FY3 8NR
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Site Not Available

  • Central Manchester University Hospitals NHS - mancester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • The James Cook University Hospital - SouthTees Hospitals NHS

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera

    Sheffield, S5 7AU
    United Kingdom

    Site Not Available

  • Alaska Heart

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Southwest EP

    Chandler, Arizona 85226
    United States

    Site Not Available

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas 72410
    United States

    Site Not Available

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas 72205-6202
    United States

    Site Not Available

  • Chula Vista Cardiac Center

    Chula Vista, California 91910
    United States

    Site Not Available

  • San Diego Arrhythmia Associates

    San Diego, California 92103
    United States

    Site Not Available

  • COR Healthcare

    Torrance, California 90505
    United States

    Site Not Available

  • Cardiovascular Consultants Medical Group (Van Nuys CA)

    Van Nuys, California 91405
    United States

    Site Not Available

  • Cardiology Associates Medical Group

    Ventura, California 93003
    United States

    Site Not Available

  • Colorado Springs Cardiology

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Denver Heart

    Denver, Colorado 80220
    United States

    Site Not Available

  • Colorado Heart and Vascular, PC

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Bradenton Cardiology

    Bradenton, Florida 99508
    United States

    Site Not Available

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Heart Rhythm Solutions

    Hollywood, Florida 33021-3552
    United States

    Site Not Available

  • Baptist Health

    Jacksonville, Florida 32207-8208
    United States

    Site Not Available

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida 32405
    United States

    Site Not Available

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida 34695-6604
    United States

    Site Not Available

  • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Phoebe Putney Memorial Hospital

    Albany, Georgia 31701-1943
    United States

    Site Not Available

  • Deaconess Specialty Physicians

    Evansville, Indiana 47710
    United States

    Site Not Available

  • Iowa Heart Center (West Des Moines IA)

    Des Moines, Iowa 50266
    United States

    Site Not Available

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160-8500
    United States

    Site Not Available

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Norton Heart Specialists

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Norton Heart and Vascular Institute

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Our Lady of the Lake Office of Research

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Tidal Health Peninsula Regional

    Salisbury, Maryland 21801
    United States

    Site Not Available

  • Associates in Cardiology PA

    Silver Spring, Maryland 20910-1265
    United States

    Site Not Available

  • MedStar Health Research Institute (Baltimore)

    Towson, Maryland 21204-7733
    United States

    Site Not Available

  • Brigham and Women's Hospital (Boston MA)

    Boston, Massachusetts 02115-6110
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • UP Health System - Marquette

    Marquette, Michigan 49855-2705
    United States

    Site Not Available

  • Michigan Heart

    Ypsilanti, Michigan 48197-8633
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407-1157
    United States

    Site Not Available

  • North Memorial Health Heart & Vascular Center

    Robbinsdale, Minnesota 55422-2926
    United States

    Site Not Available

  • Mayo Clinic (Rochester MN)

    Rochester, Minnesota 55902-1906
    United States

    Site Not Available

  • Missouri Cardiovascular Specialists

    Columbia, Missouri 65201-8023
    United States

    Site Not Available

  • University Hospital (Columbia MO)

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Saint Lukes Health System

    Kansas City, Missouri 64111-5934
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Nebraska Medicine

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Monmouth Cardiology Associates

    Ocean City, New Jersey 07712-4764
    United States

    Site Not Available

  • Presbyterian Heart Group

    Albuquerque, New Mexico 87106-4921
    United States

    Site Not Available

  • South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Huntington Hospital

    Huntington, New York 11743
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Northern Westchester Hospital

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Northwell Health

    Multiple Locations, New York 11030
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York 10021
    United States

    Site Not Available

  • NewYork-Presbyterian/Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York City, New York 10075
    United States

    Site Not Available

  • Hudson Valley Heart Center

    Poughkeepsie, New York 12601-3923
    United States

    Site Not Available

  • Staten Island University Hospital

    Staten Island, New York 10305-3436
    United States

    Site Not Available

  • Duke University Medical Center (DUMC)

    Durham, North Carolina 27705
    United States

    Site Not Available

  • WakeMed Health & Hospitals

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

    Akron, Ohio 44304-1473
    United States

    Site Not Available

  • The Christ Hospital Health Network

    Cincinati, Ohio 45219
    United States

    Site Not Available

  • The Christ Hospital Health Network

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267-0542
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • St Luke's University Health Network

    Bethlehem, Pennsylvania 18015-1000
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • UPMC Heart and Vascular Institute at UPMC Hamot

    Erie, Pennsylvania 16507-1579
    United States

    Site Not Available

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Site Not Available

  • Saint Thomas Research Institute

    Nashville, Tennessee 37205-2018
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705-1852
    United States

    Site Not Available

  • Consultants in Cardiology (Fort Worth TX)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Heart Center of North Texas

    Fort Worth, Texas 761014
    United States

    Site Not Available

  • EP Heart

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • The University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Kootenai Heart Clinics Northwest

    Spokane, Washington 99204-2352
    United States

    Site Not Available

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin 53215-3678
    United States

    Site Not Available

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