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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496518
• Other study ID #: iATP PAS
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: January 31, 2027

Study information

• Verified date: August 2023
• Source: Medtronic
• Contact: iATP PAS Study Manager
• Phone: 1-800-633-8766
• Email: rs.productsurveillanceregistry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Intrinsic Antitachycardia Pacing (iATP) Therapy
iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

Locations

Country	Name	City	State
France	Clinique Rhône Durance	Avignon
France	Centre Hospitalier de la Côte Basque	Bayonne
France	CHU de Brest	Brest
France	CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol	Caen
France	Générale de Santé - Hôpital Privé Saint Martin	Caen
France	CHU Clermont-Ferrand - Gabriel-Montpied	Clermont-Ferrand
France	CHU de Dijon - Hospital Le Bocage	Dijon
France	CHRU La Rochelle	La Rochelle
France	Hopital prive Clairval - Ramsay Sante	Marseille
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
Greece	Hygeia Hospital	Athens
Greece	Athens Medical Center	Maroúsi
Italy	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
Portugal	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
Slovakia	Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)	Bratislava
Spain	Hospital Universitario da coruna	Coruna
Spain	Hospital Universitario Clínico San Cecilio	Granda
Spain	Hospital Universitario Virgen de las Nieves	Granda
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Complejo Universitario de Salamanca	Salamanca
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago
Spain	Hospital Universitario Nuestra Señora de Candelaria	Tenerife
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Cardiopark Zurich	Zürich
United Kingdom	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 States	Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists	Akron	Ohio
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Alaska Heart	Anchorage	Alaska
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Our Lady of the Lake Office of Research	Baton Rouge	Louisiana
United States	South Shore University Hospital	Bay Shore	New York
United States	St Luke's University Health Network	Bethlehem	Pennsylvania
United States	Brigham and Women's Hospital (Boston MA)	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southwest EP	Chandler	Arizona
United States	Chula Vista Cardiac Center	Chula Vista	California
United States	The Christ Hospital Health Network	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Colorado Springs Cardiology	Colorado Springs	Colorado
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	University Hospital (Columbia MO)	Columbia	Missouri
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Denver Heart	Denver	Colorado
United States	Iowa Heart Center (West Des Moines IA)	Des Moines	Iowa
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
United States	Saint Elizabeth Healthcare	Edgewood	Kentucky
United States	UPMC Heart and Vascular Institute at UPMC Hamot	Erie	Pennsylvania
United States	Deaconess Specialty Physicians	Evansville	Indiana
United States	Consultants in Cardiology (Fort Worth TX)	Fort Worth	Texas
United States	Heart Center of North Texas	Fort Worth	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Heart Rhythm Solutions	Hollywood	Florida
United States	Huntington Hospital	Huntington	New York
United States	Baptist Health	Jacksonville	Florida
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Saint Lukes Health System	Kansas City	Missouri
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Colorado Heart and Vascular, PC	Lakewood	Colorado
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Saint Vincent Heart Clinic Arkansas	Little Rock	Arkansas
United States	Norton Heart Specialists	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	UP Health System - Marquette	Marquette	Michigan
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	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	Monmouth Cardiology Associates	Ocean City	New Jersey
United States	Nebraska Medicine	Omaha	Nebraska
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida
United States	Hudson Valley Heart Center	Poughkeepsie	New York
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	North Memorial Health Heart & Vascular Center	Robbinsdale	Minnesota
United States	Mayo Clinic (Rochester MN)	Rochester	Minnesota
United States	Heart & Vascular Institute of Florida	Safety Harbor	Florida
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Tidal Health Peninsula Regional	Salisbury	Maryland
United States	San Diego Arrhythmia Associates	San Diego	California
United States	Heart Rhythm Consultants P.A. (Sarasota Memorial Research)	Sarasota	Florida
United States	Associates in Cardiology PA	Silver Spring	Maryland
United States	Kootenai Heart Clinics Northwest	Spokane	Washington
United States	Staten Island University Hospital	Staten Island	New York
United States	EP Heart	The Woodlands	Texas
United States	COR Healthcare	Torrance	California
United States	Cardiovascular Consultants Medical Group (Van Nuys CA)	Van Nuys	California
United States	Cardiology Associates Medical Group	Ventura	California
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  France,  Greece,  Italy,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To demonstrate the success rate of iATP in the FVT zone is greater than 70%	Demonstrating success rate of iATP	Approximately 5 years
Secondary	To characterize arrhythmia-related syncope events	characterizing arrhythmia-related syncope events	Approximately 5 years
Secondary	To characterize unnecessary and inappropriate shocks	characterizing unnecessary and inappropriate shocks	Approximately 5 years