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

August 29, 2023 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

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 Contact

Study Locations

  • France
      • Avignon, France, 84082
        • Recruiting
        • Clinique Rhône Durance
        • Contact:
        • Principal Investigator:
          • François Xavier Hager, M.D.
      • Bayonne, France, 64109
        • Not yet recruiting
        • Centre Hospitalier de la Côte Basque
        • Contact:
          • Site Coordinator
          • Phone Number: +33 676309286
        • Principal Investigator:
          • Julien Laborderie, Dr
      • Brest, France, 29609
        • Recruiting
        • CHU de Brest
        • Contact:
          • Site Coordinator
          • Phone Number: +33 298347151
        • Principal Investigator:
          • Jacques Mansourati, Prof
      • Caen, France, 14000
        • Recruiting
        • Générale de Santé - Hôpital Privé Saint Martin
        • Contact:
        • Principal Investigator:
          • Alain Lebon, Dr
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
        • Contact:
        • Principal Investigator:
          • Pierre Ollitrault, Dr
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand - Gabriel-Montpied
        • Contact:
          • Site Coordinator
          • Phone Number: +33 473754109
        • Principal Investigator:
          • Romain Eschalier, Prof
      • Dijon, France, 21079
        • Recruiting
        • CHU de Dijon - Hospital Le Bocage
        • Contact:
        • Principal Investigator:
          • Géraldine Bertaux, Dr
      • La Rochelle, France, 17019
        • Recruiting
        • CHRU La Rochelle
        • Contact:
          • Site Coordinator
          • Phone Number: +33 516494165
        • Principal Investigator:
          • Antoine Milhem, Dr
      • Marseille, France, 13009
        • Not yet recruiting
        • Hopital prive Clairval - Ramsay Sante
        • Contact:
          • Site Coordinator
        • Principal Investigator:
          • Alexis Mechulan, Dr
      • Nantes, France, 44277
        • Recruiting
        • Nouvelles Cliniques Nantaises
        • Contact:
          • Site Coordinator
          • Phone Number: +33 228255654
        • Principal Investigator:
          • Daniel Gras, Prof
      • Pringy, France, 74374
        • Recruiting
        • Centre Hospitalier de la Région d'Annecy
        • Contact:
          • Site Coordinator
          • Phone Number: +33 450636684
        • Principal Investigator:
          • Antoine Dompnier, Dr
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • Centre Hospitalier Universitaire Saint Etienne
        • Contact:
          • Site Coordinator
          • Phone Number: +33 477829081
        • Principal Investigator:
          • Antoine Da Costa, Prof
      • Villeurbanne, France, 69100
        • Recruiting
        • Capio - Clinique du Tonkin
        • Contact:
          • Site Coordinator
          • Phone Number: +33 437484805
        • Principal Investigator:
          • Hervé Poty, Dr
  • Greece
      • Athens, Greece, 15123
        • Recruiting
        • Hygeia Hospital
        • Principal Investigator:
          • Theodoros Apostolopoulos, Dr
        • Contact:
          • Site Coordinator
          • Phone Number: +30 6972831109
      • Maroúsi, Greece, 15125
        • Recruiting
        • Athens Medical Center
        • Principal Investigator:
          • Dimitrios Tsiachris, Dr
        • Contact:
          • Site Coordinator
          • Phone Number: +30 6932279620
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico Sant' Orsola - Malpighi
        • Principal Investigator:
          • Igor Diemberger, Prof
        • Contact:
          • Site Coordinator
          • Phone Number: +39 516363867
      • Castrovillari, Italy, 87012
        • Recruiting
        • Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"
        • Principal Investigator:
          • Giovanni Bisignani, Dr
        • Contact:
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale "Vito Fazzi" Lecce
        • Contact:
        • Principal Investigator:
          • Ennio Carmine Luigi Pisanò, Dr
      • Milano, Italy, 20162
        • Recruiting
        • Azienda Ospedaliera ospedale Niguarada ca Granda
        • Principal Investigator:
          • Giuseppe Cattafi, Dr
      • Taranto, Italy, 74024
        • Recruiting
        • Presidio Ospedaliero Centrale - SS.Annunziata
        • Principal Investigator:
          • Giovanni Luzzi, Dr
      • Udine, Italy, 33100
        • Recruiting
        • Azienda ospedaleria Santa Maria dellaMisericordia di Udine
        • Principal Investigator:
          • Domenico Facchin, Dr
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Recruiting
        • Hospital da Senhora da Oliveira -Guimarães
        • Principal Investigator:
          • Víctor Sanfins, Dr
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE
        • Contact:
          • Site Coordinator
          • Phone Number: +351 965500663
        • Principal Investigator:
          • João Manuel Frazão Rodrigues de Sousa, Dr
      • Porto, Portugal, 4200-319
        • Recruiting
        • Centro Hospitalar Universitário de SãoJoão Alameda
        • Contact:
          • Luis Adao
        • Principal Investigator:
          • Luís Adão, Dr
      • Santarém, Portugal, 2000-177
        • Recruiting
        • Hospital Distrital de Santarém
        • Principal Investigator:
          • Vitor Martins, Dr
  • Slovakia
      • Bratislava, Slovakia
        • Recruiting
        • Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
        • Principal Investigator:
          • Michal Sasov, M.D.
  • Spain
      • Coruna, Spain, 15006
        • Recruiting
        • Hospital Universitario da Coruña
        • Principal Investigator:
          • Luisa Pérez Álvarez, Dr
      • Granda, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Principal Investigator:
          • Pablo Sánchez, Dr
      • Granda, Spain, 18016
        • Recruiting
        • Hospital Universitario Clinico San Cecilio
        • Principal Investigator:
          • Sebastián Giacomán, Dr.
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Rafael Salguero Bodes, Dr
      • Salamanca, Spain, 37007
        • Recruiting
        • Complejo Universitario de Salamanca
        • Principal Investigator:
          • Javier Jiménez Candil, Dr
      • Santiago, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago de Compostela
        • Principal Investigator:
          • José Luis Martínez Sande, Dr
      • Tenerife, Spain, 38010
        • Recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Principal Investigator:
          • Luis Álvarez, Dr
      • Valladolid, Spain, 47006
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
        • Principal Investigator:
          • Maria Gracia Sandín, Dr
  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève
        • Contact:
          • Site Coordinator
          • Phone Number: +41 223727200
        • Principal Investigator:
          • Haran Burri, Prof
      • Zürich, Switzerland, 8027
        • Recruiting
        • Cardiopark Zurich
        • Principal Investigator:
          • Eva Buhlmann, Dr
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
        • Principal Investigator:
          • Francisco Leyva-Leon, Prof
      • Blackpool, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital
        • Principal Investigator:
          • Alison Seed, Dr
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
        • Principal Investigator:
          • Archana Rao, Dr
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust Hammersmith Hospital
        • Principal Investigator:
          • Zachary Whinnett, Dr
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Central Manchester University Hospitals NHS - mancester Royal Infirmary
        • Principal Investigator:
          • Amir Zaidi, Dr
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • The James Cook University Hospital - SouthTees Hospitals NHS
        • Principal Investigator:
          • Nicholas John Linker, Prof
      • Sheffield, United Kingdom, S5 7AU
        • Recruiting
        • Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera
        • Principal Investigator:
          • Nigel Lewis, Dr
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Not yet recruiting
        • Alaska Heart
        • Contact:
          • Site Coordinator
          • Phone Number: 907-561-3211
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Recruiting
        • Southwest EP
        • Contact:
          • Site Coordinator
          • Phone Number: 480-776-6844
        • Principal Investigator:
          • Drory Tendler, M.D.
    • Arkansas
      • Jonesboro, Arkansas, United States, 72410
        • Not yet recruiting
        • Cardiology Associates of Northeast Arkansas
        • Contact:
          • Site Coordinator
          • Phone Number: 870-207-3827
      • Little Rock, Arkansas, United States, 72205-6202
        • Recruiting
        • Saint Vincent Heart Clinic Arkansas
        • Principal Investigator:
          • Mangaraju Chakka, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 501-255-6030
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Chula Vista Cardiac Center
        • Principal Investigator:
          • Brett Berman, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 619-934-3260
      • San Diego, California, United States, 92103
        • Not yet recruiting
        • San Diego Arrhythmia Associates
        • Contact:
          • Site Coordinator
          • Phone Number: 619-297-0014
      • Torrance, California, United States, 90505
        • Not yet recruiting
        • COR Healthcare
        • Contact:
          • Site Coordinator
          • Phone Number: 310-792-5800
      • Van Nuys, California, United States, 91405
        • Recruiting
        • Cardiovascular Consultants Medical Group (Van Nuys CA)
        • Contact:
          • Site Coordinator
          • Phone Number: 310-824-3378
        • Principal Investigator:
          • Isaac Wiener, M.D.
      • Ventura, California, United States, 93003
        • Recruiting
        • Cardiology Associates Medical Group
        • Principal Investigator:
          • Jonathan Dukes, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 661-904-4503
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Colorado Springs Cardiology
        • Contact:
          • Site Coordinator
          • Phone Number: 719-776-2514
        • Principal Investigator:
          • Christopher Cole, M.D.
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Denver Heart
        • Contact:
          • Site Coordinator
          • Phone Number: 303-331-9121
        • Principal Investigator:
          • Christopher Stees, M.D.
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Heart and Vascular, PC
        • Contact:
          • Site Coordinator
          • Phone Number: 303-595-2727
        • Principal Investigator:
          • Ganesh Venkataraman, M.D.
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Contact:
          • Site Coordinator
          • Phone Number: 860-972-1964
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Contact:
          • Site Coordinator
          • Phone Number: 203-466-8177
        • Principal Investigator:
          • Rachel Lampert, M.D.
    • Florida
      • Clearwater, Florida, United States, 33756
        • Not yet recruiting
        • Clearwater Cardiovascular Consultants
        • Contact:
          • Study Coordinator
          • Phone Number: 727-451-1683
      • Hollywood, Florida, United States, 33021-3552
        • Recruiting
        • Heart Rhythm Solutions
        • Contact:
          • Site Coordinator
          • Phone Number: 954-707-5200
        • Principal Investigator:
          • Awais Humayun, M.D.
      • Jacksonville, Florida, United States, 32207-8208
        • Recruiting
        • Baptist Health
        • Contact:
          • Site Coordinator
          • Phone Number: 904-271-6343
      • Panama City, Florida, United States, 32405
        • Recruiting
        • Cardiovascular Institute of Northwest Florida
        • Contact:
          • Site Coordinator
          • Phone Number: 850-769-0329
        • Principal Investigator:
          • Nghia Hoang, M.D.
      • Safety Harbor, Florida, United States, 34695-6604
        • Not yet recruiting
        • Heart & Vascular Institute of Florida
        • Contact:
          • Site Coordinator
          • Phone Number: 727-512-8047
      • Sarasota, Florida, United States, 34233
        • Recruiting
        • Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
        • Contact:
          • Site Coordinator
          • Phone Number: 941-917-1669
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Recruiting
        • Deaconess Specialty Physicians
        • Principal Investigator:
          • Chandrashekar Kumbar, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 812-490-4505
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Recruiting
        • Iowa Heart Center (West Des Moines IA)
        • Principal Investigator:
          • Dwayne Campbell, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 515-235-5089
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • Recruiting
        • The University of Kansas Medical Center
        • Principal Investigator:
          • Martin Emert, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 913-588-9679
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Not yet recruiting
        • Saint Elizabeth Healthcare
        • Contact:
          • Site Coordinator
          • Phone Number: 859-301-4729
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Norton Heart Specialists
        • Principal Investigator:
          • Robert Schwartz, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 502-891-8656
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Not yet recruiting
        • Our Lady of the Lake Office of Research
        • Contact:
          • Site Coordinator
          • Phone Number: 225-765-7659
    • Maryland
      • Salisbury, Maryland, United States, 21801
        • Recruiting
        • Tidal Health Peninsula Regional
        • Principal Investigator:
          • Steven Hearne, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 410-334-2333
      • Silver Spring, Maryland, United States, 20910-1265
        • Recruiting
        • Associates in Cardiology PA
        • Contact:
          • Site Coordinator
          • Phone Number: 301-681-5700
        • Principal Investigator:
          • Michael Lincoln, M.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
          • Site Coordinator
          • Phone Number: 617-726-5093
      • Boston, Massachusetts, United States, 02115-6110
        • Recruiting
        • Brigham and Women's Hospital (Boston MA)
        • Principal Investigator:
          • Melanie Maytin, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 617-732-5241
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Clinical Research Institute
        • Principal Investigator:
          • John Ip, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 517-364-5732
      • Marquette, Michigan, United States, 49855-2705
        • Not yet recruiting
        • UP Health System - Marquette
        • Contact:
          • Site Coordinator
          • Phone Number: 906-225-3870
      • Ypsilanti, Michigan, United States, 48197-8633
        • Recruiting
        • Michigan Heart
        • Principal Investigator:
          • Jihn Han, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 734-712-8252
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422-2926
        • Not yet recruiting
        • North Memorial Health Heart & Vascular Center
        • Contact:
          • Site Coordinator
          • Phone Number: 763-581-6714
      • Rochester, Minnesota, United States, 55902-1906
        • Recruiting
        • Mayo Clinic (Rochester MN)
        • Contact:
          • Site Coordinator
          • Phone Number: 507-266-2328
        • Principal Investigator:
          • Abhishek Deshmukh, M.D.
    • Missouri
      • Columbia, Missouri, United States, 65201-8023
        • Recruiting
        • Missouri Cardiovascular Specialists
        • Contact:
          • Site Coordinator
          • Phone Number: 573-256-3094
        • Principal Investigator:
          • Daniel Pierce, M.D.
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • University Hospital (Columbia MO)
        • Contact:
          • Site Coordinator
          • Phone Number: 573-884-4099
        • Principal Investigator:
          • Mauricio Sendra, M.D.
      • Kansas City, Missouri, United States, 64111-5934
        • Recruiting
        • Saint Lukes Health System
        • Contact:
          • Site Coordinator
          • Phone Number: 816-932-6275
        • Principal Investigator:
          • Brain Ramza, M.D.
      • Saint Louis, Missouri, United States, 63110-1010
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Mitchell Faddis, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 314-454-7422
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • Nebraska Medicine
        • Principal Investigator:
          • Shane Tsai, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 402-559-4067
    • New Jersey
      • Ocean City, New Jersey, United States, 07712-4764
        • Recruiting
        • Monmouth Cardiology Associates
        • Contact:
          • Site Coordinator
          • Phone Number: 1129 732-663-0300
        • Principal Investigator:
          • L Steven Zukerman, M.D.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4921
        • Recruiting
        • Presbyterian Heart Group
        • Contact:
          • Site Coordinator
          • Phone Number: 505-563-2716
        • Principal Investigator:
          • Lawrence Nair, M.D.
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • South Shore University Hospital
        • Contact:
          • Site Coordinator
          • Phone Number: 631-968-3009
        • Principal Investigator:
          • Jonathan Willner, M.D.
      • Huntington, New York, United States, 11743
        • Recruiting
        • Huntington Hospital
        • Principal Investigator:
          • Jonathan Willner, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 631-547-7191
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
          • Site Coordinator
          • Phone Number: 631-968-3009
        • Principal Investigator:
          • Jonathan Willner, M.D.
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northern Westchester Hospital
        • Principal Investigator:
          • Jonathan Willner, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 914-362-6199
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Long Island Jewish Medical Center
        • Principal Investigator:
          • Jonathan Willner, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 516-881-7027
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Jonathan Willner, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 212-434-3934
      • New York, New York, United States, 10021
        • Recruiting
        • New York-Presbyterian Hospital/Weill Cornell Medical Center
        • Principal Investigator:
          • Steven Markowitz, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 212-746-4617
      • New York, New York, United States, 10032
        • Recruiting
        • NewYork-Presbyterian/Columbia University Irving Medical Center
        • Contact:
          • Site Coordinator
          • Phone Number: 845-866-6426
        • Principal Investigator:
          • Fredrick Ehlert, M.D.
      • Poughkeepsie, New York, United States, 12601-3923
        • Recruiting
        • Hudson Valley Heart Center
        • Contact:
          • Site Coordinator
          • Phone Number: 51217 845-473-1188
        • Principal Investigator:
          • Sankar Varanasi, M.D.
      • Staten Island, New York, United States, 10305-3436
        • Recruiting
        • Staten Island University Hospital
        • Principal Investigator:
          • Jonathan Willner, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 718-226-7953
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Duke University Medical Center (DUMC)
        • Contact:
          • Site Coordinator
          • Phone Number: 919-681-8983
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed Health & Hospitals
        • Contact:
          • Site Coordinator
          • Phone Number: 919-350-5252
        • Principal Investigator:
          • Marc Silver, M.D.
    • Ohio
      • Akron, Ohio, United States, 44304-1473
        • Recruiting
        • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
        • Contact:
          • Site Coordinator
          • Phone Number: 330-375-6673
        • Principal Investigator:
          • Michael Pelini, M.D.
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital Health Network
        • Contact:
          • Site Coordinator
          • Phone Number: 513-585-2159
        • Principal Investigator:
          • Dean Kereiakes, M.D.
      • Cincinnati, Ohio, United States, 45267-0542
        • Not yet recruiting
        • University of Cincinnati
        • Contact:
          • Site Coordinator
          • Phone Number: 513-558-3415
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
          • Site Coordinator
          • Phone Number: 216-444-4959
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015-1000
        • Recruiting
        • St Luke's University Health Network
        • Principal Investigator:
          • Darren Traub, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 484-526-7827
      • Danville, Pennsylvania, United States, 17822
        • Not yet recruiting
        • Geisinger Medical Center
        • Contact:
          • Site Coordinator
          • Phone Number: 570-214-4964
      • Erie, Pennsylvania, United States, 16507-1579
        • Not yet recruiting
        • UPMC Heart and Vascular Institute at UPMC Hamot
        • Contact:
          • Site Coordinator
          • Phone Number: 814-877-2082
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Not yet recruiting
        • Geisinger Wyoming Valley Medical Center
        • Contact:
          • Site Coordinator
          • Phone Number: 570-808-6123
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Site Coordinator
          • Phone Number: 615-343-8647
      • Nashville, Tennessee, United States, 37205-2018
        • Recruiting
        • Saint Thomas Research Institute
        • Principal Investigator:
          • James Baker, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 615-222-3870
    • Texas
      • Austin, Texas, United States, 78705-1852
        • Recruiting
        • Texas Cardiac Arrhythmia Research Foundation
        • Contact:
          • Site Coordinator
          • Phone Number: 512-522-9410
        • Principal Investigator:
          • Robert Canby, M.D.
      • Fort Worth, Texas, United States, 761014
        • Recruiting
        • Heart Center of North Texas
        • Principal Investigator:
          • Aleem Mughal, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 817-334-2800
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Consultants in Cardiology (Fort Worth TX)
        • Principal Investigator:
          • Theodore Takata, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 817-250-1950
      • The Woodlands, Texas, United States, 77384
        • Not yet recruiting
        • EP Heart
        • Contact:
          • Site Coordinator
          • Phone Number: 713-486-1637
    • Washington
      • Spokane, Washington, United States, 99204-2352
        • Not yet recruiting
        • Kootenai Heart Clinics Northwest
        • Contact:
          • Site Coordinator
          • Phone Number: 509-847-2500
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215-3678
        • Recruiting
        • Aurora Cardiovascular Services
        • Principal Investigator:
          • Jodi Lyn Zilinski, M.D.
        • Contact:
          • Site Coordinator
          • Phone Number: 262-249-5432

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 (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2027

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 (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iATP PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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