Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
- Conditions
- Ventricular Tachycardia
- Interventions
- Device: Intrinsic Antitachycardia Pacing (iATP) Therapy
- Registration Number
- NCT04496518
- Lead Sponsor
- Medtronic
- 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).
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2200
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with ICD/CRT device with iATP programmed on Intrinsic Antitachycardia Pacing (iATP) Therapy 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method To characterize arrhythmia-related syncope events Approximately 5 years characterizing arrhythmia-related syncope events
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 unnecessary and inappropriate shocks Approximately 5 years characterizing unnecessary and inappropriate shocks
Trial Locations
- Locations (92)
The Christ Hospital Health Network
🇺🇸Cincinati, Ohio, United States
Central Manchester University Hospitals NHS - mancester Royal Infirmary
🇬🇧Manchester, United Kingdom
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
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
🇬🇷Maroúsi, 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
🇮🇹Milano, Italy
Presidio Ospedaliero Centrale - SS.Annunziata
🇮🇹Taranto, Italy
Azienda ospedaleria Santa Maria dellaMisericordia di Udine
🇮🇹Udine, Italy
Norton Heart and Vascular Institute
🇺🇸Louisville, Kentucky, United States
Hospital da Senhora da Oliveira -Guimarães
🇵🇹Guimarães, Portugal
Southwest EP
🇺🇸Chandler, Arizona, United States
Cardiology Associates Medical Group
🇺🇸Ventura, California, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Saint Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Chula Vista Cardiac Center
🇺🇸Chula Vista, California, United States
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
🇪🇸Coruna, Spain
Cardiovascular Consultants Medical Group (Van Nuys CA)
🇺🇸Van Nuys, California, United States
Hospital Universitario Virgen de las Nieves
🇪🇸Granda, Spain
Hospital Universitario Clínico San Cecilio
🇪🇸Granda, Spain
Complejo Universitario de Salamanca
🇪🇸Salamanca, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago, Spain
Colorado Springs Cardiology
🇺🇸Colorado Springs, Colorado, United States
Denver Heart
🇺🇸Denver, Colorado, United States
Colorado Heart and Vascular, PC
🇺🇸Lakewood, Colorado, United States
Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
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
Brigham and Women's Hospital (Boston MA)
🇺🇸Boston, Massachusetts, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Tidal Health Peninsula Regional
🇺🇸Salisbury, Maryland, United States
Associates in Cardiology PA
🇺🇸Silver Spring, Maryland, United States
Hôpitaux Universitaires de Genève
🇨🇭Geneva, Switzerland
Mayo Clinic (Rochester MN)
🇺🇸Rochester, Minnesota, United States
Missouri Cardiovascular Specialists
🇺🇸Columbia, Missouri, United States
University Hospital (Columbia MO)
🇺🇸Columbia, Missouri, United States
Liverpool Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Saint Lukes Health System
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint 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
Lenox Hill Hospital
🇺🇸New York City, New York, United States
Hudson Valley Heart Center
🇺🇸Poughkeepsie, 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
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
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
Cardiopark Zurich
🇨🇭Zürich, Switzerland
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Tenerife, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Imperial College Healthcare NHS Trust Hammersmith Hospital
🇬🇧London, United Kingdom
The James Cook University Hospital - SouthTees Hospitals NHS
🇬🇧Middlesbrough, United Kingdom
Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera
🇬🇧Sheffield, United Kingdom