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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrinsic Antitachycardia Pacing (iATP) Therapy | Device | iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60% | Demonstrating success rate of iATP | Approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the success rate of iATP in the FVT zone is greater than 70% | Demonstrating success rate of iATP | Approximately 5 years |
| To characterize arrhythmia-related syncope events | characterizing arrhythmia-related syncope events |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest EP | Chandler | Arizona | 85226 | United States | ||
| Saint Vincent Heart Clinic Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39694452 | Derived | Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail. 2025 May;31(5):824-832. doi: 10.1016/j.cardfail.2024.11.011. Epub 2024 Dec 16. |
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| Approximately 5 years |
| To characterize unnecessary and inappropriate shocks | characterizing unnecessary and inappropriate shocks | Approximately 5 years |
| Little Rock |
| Arkansas |
| 72205-6202 |
| United States |
| Chula Vista Cardiac Center | Chula Vista | California | 91910 | United States |
| Cardiovascular Consultants Medical Group (Van Nuys CA) | Van Nuys | California | 91405 | United States |
| Cardiology Associates Medical Group | Ventura | California | 93003 | United States |
| Colorado Springs Cardiology | Colorado Springs | Colorado | 80907 | United States |
| Denver Heart | Denver | Colorado | 80220 | United States |
| Colorado Heart and Vascular, PC | Lakewood | Colorado | 80228 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Heart Rhythm Solutions | Hollywood | Florida | 33021-3552 | United States |
| Baptist Health | Jacksonville | Florida | 32207-8208 | United States |
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | 32405 | United States |
| Heart & Vascular Institute of Florida | Safety Harbor | Florida | 34695-6604 | United States |
| Heart Rhythm Consultants P.A. (Sarasota Memorial Research) | Sarasota | Florida | 34233 | United States |
| Deaconess Specialty Physicians | Evansville | Indiana | 47710 | United States |
| Iowa Heart Center (West Des Moines IA) | Des Moines | Iowa | 50266 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160-8500 | United States |
| Norton Heart and Vascular Institute | Louisville | Kentucky | 40205 | United States |
| Tidal Health Peninsula Regional | Salisbury | Maryland | 21801 | United States |
| Associates in Cardiology PA | Silver Spring | Maryland | 20910-1265 | United States |
| Brigham and Women's Hospital (Boston MA) | Boston | Massachusetts | 02115-6110 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197-8633 | United States |
| Mayo Clinic (Rochester MN) | Rochester | Minnesota | 55902-1906 | United States |
| Missouri Cardiovascular Specialists | Columbia | Missouri | 65201-8023 | United States |
| University Hospital (Columbia MO) | Columbia | Missouri | 65201 | United States |
| Saint Lukes Health System | Kansas City | Missouri | 64111-5934 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1010 | United States |
| Nebraska Medicine | Omaha | Nebraska | 68105 | United States |
| Monmouth Cardiology Associates | Ocean City | New Jersey | 07712-4764 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106-4921 | United States |
| South Shore University Hospital | Bay Shore | New York | 11706 | United States |
| Huntington Hospital | Huntington | New York | 11743 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10021 | United States |
| NewYork-Presbyterian/Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Hudson Valley Heart Center | Poughkeepsie | New York | 12601-3923 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305-3436 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists | Akron | Ohio | 44304-1473 | United States |
| The Christ Hospital Health Network | Cincinati | Ohio | 45219 | United States |
| St Luke's University Health Network | Bethlehem | Pennsylvania | 18015-1000 | United States |
| Saint Thomas Research Institute | Nashville | Tennessee | 37205-2018 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705-1852 | United States |
| Heart Center of North Texas | Fort Worth | Texas | 761014 | United States |
| Consultants in Cardiology (Fort Worth TX) | Fort Worth | Texas | 76104 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215-3678 | United States |
| Clinique Rhône Durance | Avignon | 84082 | France |
| CHU de Brest | Brest | 29609 | France |
| Générale de Santé - Hôpital Privé Saint Martin | Caen | 14000 | France |
| CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol | Caen | 14033 | France |
| CHU Clermont-Ferrand - Gabriel-Montpied | Clermont-Ferrand | 63003 | France |
| CHU de Dijon - Hospital Le Bocage | Dijon | 21079 | France |
| CHRU La Rochelle | La Rochelle | 17019 | France |
| Nouvelles Cliniques Nantaises | Nantes | 44277 | France |
| Centre hospitalier de la région d'Annecy | Pringy | 74374 | France |
| Centre Hospitalier Universitaire Saint Étienne | Saint-Priest-en-Jarez | 42270 | France |
| Capio - Clinique du Tonkin | Villeurbanne | 69100 | France |
| Hygeia Hospital | Athens | 15123 | Greece |
| Athens Medical Center | Marousi | 15125 | Greece |
| Policlinico Sant' Orsola - Malpighi | Bologna | 40138 | Italy |
| Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari" | Castrovillari | 87012 | Italy |
| Ospedale "Vito Fazzi" Lecce | Lecce | 73100 | Italy |
| Azienda Ospedaliera ospedale Niguarada ca Granda | Milan | 20162 | Italy |
| Presidio Ospedaliero Centrale - SS.Annunziata | Taranto | 74024 | Italy |
| Azienda ospedaleria Santa Maria dellaMisericordia di Udine | Udine | 33100 | Italy |
| Hospital da Senhora da Oliveira -Guimarães | Guimarães | 4835-044 | Portugal |
| Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Universitário de SãoJoão Alameda | Porto | 4200-319 | Portugal |
| Hospital Distrital de Santarém | Santarém | 2000-177 | Portugal |
| Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.) | Bratislava | Slovakia |
| Hospital Universitario da coruna | A Coruña | 15006 | Spain |
| Hospital Universitario Virgen de las Nieves | Granda | 18014 | Spain |
| Hospital Universitario Clínico San Cecilio | Granda | 18016 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Complejo Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago | 15706 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47006 | Spain |
| Hôpitaux Universitaires de Genève | Geneva | 1205 | Switzerland |
| Cardiopark Zurich | Zurich | 8027 | Switzerland |
| University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital | Blackpool | FY3 8NR | United Kingdom |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | L14 3PE | United Kingdom |
| Imperial College Healthcare NHS Trust Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Central Manchester University Hospitals NHS - mancester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| The James Cook University Hospital - SouthTees Hospitals NHS | Middlesbrough | TS4 3BW | United Kingdom |
| Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera | Sheffield | S5 7AU | United Kingdom |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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