Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
NCT ID: NCT04496518
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2200 participants
OBSERVATIONAL
2020-08-01
2028-01-31
Brief Summary
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The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Intrinsic Antitachycardia Pacing (iATP) Therapy
iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).
Interventions
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Intrinsic Antitachycardia Pacing (iATP) Therapy
iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).
Eligibility Criteria
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Inclusion Criteria
* 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 is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
ALL
Yes
Sponsors
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Medtronic
INDUSTRY
Responsible Party
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Locations
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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
Yale New Haven Hospital
New Haven, Connecticut, United States
Heart Rhythm Solutions
Hollywood, Florida, United States
Baptist Health
Jacksonville, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Heart & Vascular Institute of Florida
Safety Harbor, Florida, United States
Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
Sarasota, Florida, United States
Deaconess Specialty Physicians
Evansville, Indiana, United States
Iowa Heart Center (West Des Moines IA)
Des Moines, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, United States
Tidal Health Peninsula Regional
Salisbury, Maryland, United States
Associates in Cardiology PA
Silver Spring, Maryland, United States
Brigham and Women's Hospital (Boston MA)
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, United States
University Hospital (Columbia MO)
Columbia, Missouri, United States
Saint Lukes Health System
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Medicine
Omaha, Nebraska, United States
Monmouth Cardiology Associates
Ocean City, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
South Shore University Hospital
Bay Shore, New York, United States
Huntington Hospital
Huntington, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
NewYork-Presbyterian/Columbia University Irving Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Hudson Valley Heart Center
Poughkeepsie, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States
The Christ Hospital Health Network
Cincinati, Ohio, United States
St Luke's University Health Network
Bethlehem, Pennsylvania, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Heart Center of North Texas
Fort Worth, Texas, United States
Consultants in Cardiology (Fort Worth TX)
Fort Worth, Texas, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Clinique Rhône Durance
Avignon, , France
CHU de Brest
Brest, , France
Générale de Santé - Hôpital Privé Saint Martin
Caen, , France
CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
Caen, , France
CHU Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, , France
CHU de Dijon - Hospital Le Bocage
Dijon, , France
CHRU La Rochelle
La Rochelle, , France
Nouvelles Cliniques Nantaises
Nantes, , France
Centre hospitalier de la région d'Annecy
Pringy, , France
Centre Hospitalier Universitaire Saint Étienne
Saint-Priest-en-Jarez, , France
Capio - Clinique du Tonkin
Villeurbanne, , France
Hygeia Hospital
Athens, , Greece
Athens Medical Center
Marousi, , Greece
Policlinico Sant' Orsola - Malpighi
Bologna, , Italy
Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"
Castrovillari, , Italy
Ospedale "Vito Fazzi" Lecce
Lecce, , Italy
Azienda Ospedaliera ospedale Niguarada ca Granda
Milan, , Italy
Presidio Ospedaliero Centrale - SS.Annunziata
Taranto, , Italy
Azienda ospedaleria Santa Maria dellaMisericordia di Udine
Udine, , Italy
Hospital da Senhora da Oliveira -Guimarães
Guimarães, , Portugal
Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE
Lisbon, , Portugal
Centro Hospitalar Universitário de SãoJoão Alameda
Porto, , Portugal
Hospital Distrital de Santarém
Santarém, , Portugal
Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
Bratislava, , Slovakia
Hospital Universitario da coruna
A Coruña, , Spain
Hospital Universitario Virgen de las Nieves
Granda, , Spain
Hospital Universitario Clínico San Cecilio
Granda, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Complejo Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Cardiopark Zurich
Zurich, , Switzerland
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, , United Kingdom
Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital
Blackpool, , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital
London, , United Kingdom
Central Manchester University Hospitals NHS - mancester Royal Infirmary
Manchester, , United Kingdom
The James Cook University Hospital - SouthTees Hospitals NHS
Middlesbrough, , United Kingdom
Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera
Sheffield, , United Kingdom
Countries
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Other Identifiers
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iATP PAS
Identifier Type: -
Identifier Source: org_study_id
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