Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Sponsor
Medtronic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04496518
Collaborator
(none)
2,200
114
78
19.3
0.2
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
2200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Actual Study Start Date
:
Aug 1, 2020
Anticipated Primary Completion Date
:
Jan 31, 2025
Anticipated Study Completion Date
:
Jan 31, 2027
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60% [Approximately 5 years]
Demonstrating success rate of iATP
Secondary Outcome Measures
- To demonstrate the success rate of iATP in the FVT zone is greater than 70% [Approximately 5 years]
Demonstrating success rate of iATP
- To characterize arrhythmia-related syncope events [Approximately 5 years]
characterizing arrhythmia-related syncope events
- To characterize unnecessary and inappropriate shocks [Approximately 5 years]
characterizing unnecessary and inappropriate shocks
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Heart | Anchorage | Alaska | United States | 99508 |
| 2 | Southwest EP | Chandler | Arizona | United States | 85226 |
| 3 | Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas | United States | 72410 |
| 4 | Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas | United States | 72205-6202 |
| 5 | Chula Vista Cardiac Center | Chula Vista | California | United States | 91910 |
| 6 | San Diego Arrhythmia Associates | San Diego | California | United States | 92103 |
| 7 | COR Healthcare | Torrance | California | United States | 90505 |
| 8 | Cardiovascular Consultants Medical Group (Van Nuys CA) | Van Nuys | California | United States | 91405 |
| 9 | Cardiology Associates Medical Group | Ventura | California | United States | 93003 |
| 10 | Colorado Springs Cardiology | Colorado Springs | Colorado | United States | 80907 |
| 11 | Denver Heart | Denver | Colorado | United States | 80220 |
| 12 | Colorado Heart and Vascular, PC | Lakewood | Colorado | United States | 80228 |
| 13 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 14 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 15 | Clearwater Cardiovascular Consultants | Clearwater | Florida | United States | 33756 |
| 16 | Heart Rhythm Solutions | Hollywood | Florida | United States | 33021-3552 |
| 17 | Baptist Health | Jacksonville | Florida | United States | 32207-8208 |
| 18 | Cardiovascular Institute of Northwest Florida | Panama City | Florida | United States | 32405 |
| 19 | Heart & Vascular Institute of Florida | Safety Harbor | Florida | United States | 34695-6604 |
| 20 | Heart Rhythm Consultants P.A. (Sarasota Memorial Research) | Sarasota | Florida | United States | 34233 |
| 21 | Deaconess Specialty Physicians | Evansville | Indiana | United States | 47710 |
| 22 | Iowa Heart Center (West Des Moines IA) | Des Moines | Iowa | United States | 50266 |
| 23 | The University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-8500 |
| 24 | Saint Elizabeth Healthcare | Edgewood | Kentucky | United States | 41017 |
| 25 | Norton Heart Specialists | Louisville | Kentucky | United States | 40205 |
| 26 | Our Lady of the Lake Office of Research | Baton Rouge | Louisiana | United States | 70808 |
| 27 | Tidal Health Peninsula Regional | Salisbury | Maryland | United States | 21801 |
| 28 | Associates in Cardiology PA | Silver Spring | Maryland | United States | 20910-1265 |
| 29 | MedStar Health Research Institute (Baltimore) | Towson | Maryland | United States | 21204-7733 |
| 30 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 31 | Brigham and Women's Hospital (Boston MA) | Boston | Massachusetts | United States | 02115-6110 |
| 32 | Sparrow Clinical Research Institute | Lansing | Michigan | United States | 48912 |
| 33 | UP Health System - Marquette | Marquette | Michigan | United States | 49855-2705 |
| 34 | Michigan Heart | Ypsilanti | Michigan | United States | 48197-8633 |
| 35 | North Memorial Health Heart & Vascular Center | Robbinsdale | Minnesota | United States | 55422-2926 |
| 36 | Mayo Clinic (Rochester MN) | Rochester | Minnesota | United States | 55902-1906 |
| 37 | Missouri Cardiovascular Specialists | Columbia | Missouri | United States | 65201-8023 |
| 38 | University Hospital (Columbia MO) | Columbia | Missouri | United States | 65201 |
| 39 | Saint Lukes Health System | Kansas City | Missouri | United States | 64111-5934 |
| 40 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110-1010 |
| 41 | Nebraska Medicine | Omaha | Nebraska | United States | 68105 |
| 42 | Monmouth Cardiology Associates | Ocean City | New Jersey | United States | 07712-4764 |
| 43 | Presbyterian Heart Group | Albuquerque | New Mexico | United States | 87106-4921 |
| 44 | South Shore University Hospital | Bay Shore | New York | United States | 11706 |
| 45 | Huntington Hospital | Huntington | New York | United States | 11743 |
| 46 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 47 | Northern Westchester Hospital | Mount Kisco | New York | United States | 10549 |
| 48 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 49 | New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | United States | 10021 |
| 50 | NewYork-Presbyterian/Columbia University Irving Medical Center | New York | New York | United States | 10032 |
| 51 | Lenox Hill Hospital | New York | New York | United States | 10075 |
| 52 | Hudson Valley Heart Center | Poughkeepsie | New York | United States | 12601-3923 |
| 53 | Staten Island University Hospital | Staten Island | New York | United States | 10305-3436 |
| 54 | Duke University Medical Center (DUMC) | Durham | North Carolina | United States | 27705 |
| 55 | WakeMed Health & Hospitals | Raleigh | North Carolina | United States | 27610 |
| 56 | Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists | Akron | Ohio | United States | 44304-1473 |
| 57 | The Christ Hospital Health Network | Cincinnati | Ohio | United States | 45219 |
| 58 | University of Cincinnati | Cincinnati | Ohio | United States | 45267-0542 |
| 59 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 60 | St Luke's University Health Network | Bethlehem | Pennsylvania | United States | 18015-1000 |
| 61 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 62 | UPMC Heart and Vascular Institute at UPMC Hamot | Erie | Pennsylvania | United States | 16507-1579 |
| 63 | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 64 | Saint Thomas Research Institute | Nashville | Tennessee | United States | 37205-2018 |
| 65 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 66 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705-1852 |
| 67 | Heart Center of North Texas | Fort Worth | Texas | United States | 761014 |
| 68 | Consultants in Cardiology (Fort Worth TX) | Fort Worth | Texas | United States | 76104 |
| 69 | EP Heart | The Woodlands | Texas | United States | 77384 |
| 70 | Kootenai Heart Clinics Northwest | Spokane | Washington | United States | 99204-2352 |
| 71 | Aurora Cardiovascular Services | Milwaukee | Wisconsin | United States | 53215-3678 |
| 72 | Clinique Rhône Durance | Avignon | France | 84082 | |
| 73 | Centre Hospitalier de la Côte Basque | Bayonne | France | 64109 | |
| 74 | CHU de Brest | Brest | France | 29609 | |
| 75 | Générale de Santé - Hôpital Privé Saint Martin | Caen | France | 14000 | |
| 76 | CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol | Caen | France | 14033 | |
| 77 | CHU Clermont-Ferrand - Gabriel-Montpied | Clermont-Ferrand | France | 63003 | |
| 78 | CHU de Dijon - Hospital Le Bocage | Dijon | France | 21079 | |
| 79 | CHRU La Rochelle | La Rochelle | France | 17019 | |
| 80 | Hopital prive Clairval - Ramsay Sante | Marseille | France | 13009 | |
| 81 | Nouvelles Cliniques Nantaises | Nantes | France | 44277 | |
| 82 | Centre hospitalier de la région d'Annecy | Pringy | France | 74374 | |
| 83 | Centre Hospitalier Universitaire Saint Étienne | Saint-Priest-en-Jarez | France | 42270 | |
| 84 | Capio - Clinique du Tonkin | Villeurbanne | France | 69100 | |
| 85 | Hygeia Hospital | Athens | Greece | 15123 | |
| 86 | Athens Medical Center | Maroúsi | Greece | 15125 | |
| 87 | Policlinico Sant' Orsola - Malpighi | Bologna | Italy | 40138 | |
| 88 | Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari" | Castrovillari | Italy | 87012 | |
| 89 | Ospedale "Vito Fazzi" Lecce | Lecce | Italy | 73100 | |
| 90 | Azienda Ospedaliera ospedale Niguarada ca Granda | Milano | Italy | 20162 | |
| 91 | Presidio Ospedaliero Centrale - SS.Annunziata | Taranto | Italy | 74024 | |
| 92 | Azienda ospedaleria Santa Maria dellaMisericordia di Udine | Udine | Italy | 33100 | |
| 93 | Hospital da Senhora da Oliveira -Guimarães | Guimarães | Portugal | 4835-044 | |
| 94 | Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE | Lisbon | Portugal | 1649-035 | |
| 95 | Centro Hospitalar Universitário de SãoJoão Alameda | Porto | Portugal | 4200-319 | |
| 96 | Hospital Distrital de Santarém | Santarém | Portugal | 2000-177 | |
| 97 | Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.) | Bratislava | Slovakia | ||
| 98 | Hospital Universitario da coruna | Coruna | Spain | 15006 | |
| 99 | Hospital Universitario Virgen de las Nieves | Granda | Spain | 18014 | |
| 100 | Hospital Universitario Clínico San Cecilio | Granda | Spain | 18016 | |
| 101 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 102 | Complejo Universitario de Salamanca | Salamanca | Spain | 37007 | |
| 103 | Complejo Hospitalario Universitario de Santiago de Compostela | Santiago | Spain | 15706 | |
| 104 | Hospital Universitario Nuestra Señora de Candelaria | Tenerife | Spain | 38010 | |
| 105 | Hospital Clínico Universitario de Valladolid | Valladolid | Spain | 47006 | |
| 106 | Hôpitaux Universitaires de Genève | Geneva | Switzerland | 1205 | |
| 107 | Cardiopark Zurich | Zürich | Switzerland | 8027 | |
| 108 | University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2GW | |
| 109 | Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital | Blackpool | United Kingdom | FY3 8NR | |
| 110 | Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom | L14 3PE | |
| 111 | Imperial College Healthcare NHS Trust Hammersmith Hospital | London | United Kingdom | W12 0HS | |
| 112 | Central Manchester University Hospitals NHS - mancester Royal Infirmary | Manchester | United Kingdom | M13 9WL | |
| 113 | The James Cook University Hospital - SouthTees Hospitals NHS | Middlesbrough | United Kingdom | TS4 3BW | |
| 114 | Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera | Sheffield | United Kingdom | S5 7AU |
Sponsors and Collaborators
- Medtronic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medtronic
ClinicalTrials.gov Identifier:
NCT04496518
Other Study ID Numbers:
- iATP PAS
First Posted:
Aug 3, 2020
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: