Clinical trial NCT04496518: Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Official title: Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ventricular Tachycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 2200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%
timeFrame: Approximately 5 years
Secondary outcomes:
measure: To demonstrate the success rate of iATP in the FVT zone is greater than 70%
timeFrame: Approximately 5 years
measure: To characterize arrhythmia-related syncope events
timeFrame: Approximately 5 years
measure: To characterize unnecessary and inappropriate shocks
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Southwest EP
state: Arizona
city: Little Rock
country: United States
facility: Saint Vincent Heart Clinic Arkansas
state: Arkansas
city: Chula Vista
country: United States
facility: Chula Vista Cardiac Center
state: California
city: Van Nuys
country: United States
facility: Cardiovascular Consultants Medical Group (Van Nuys CA)
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiology
state: Colorado
city: Denver
country: United States
facility: Denver Heart
state: Colorado
city: Lakewood
country: United States
facility: Colorado Heart and Vascular, PC
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Hollywood
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Safety Harbor
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Sarasota
country: United States
facility: Heart Rhythm Consultants P.A. (Sarasota Memorial Research)
state: Florida
city: Evansville
country: United States
facility: Deaconess Specialty Physicians
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center (West Des Moines IA)
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Heart and Vascular Institute
state: Kentucky
city: Salisbury
country: United States
facility: Tidal Health Peninsula Regional
state: Maryland
city: Silver Spring
country: United States
facility: Associates in Cardiology PA
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital (Boston MA)
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic (Rochester MN)
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Columbia
country: United States
facility: University Hospital (Columbia MO)
state: Missouri
city: Kansas City
country: United States
facility: Saint Lukes Health System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
city: Ocean City
country: United States
facility: Monmouth Cardiology Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York City
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian/Columbia University Irving Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Akron
country: United States
facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Cincinati
country: United States
facility: The Christ Hospital Health Network
state: Ohio
city: Bethlehem
country: United States
facility: St Luke's University Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Fort Worth
country: United States
facility: Consultants in Cardiology (Fort Worth TX)
state: Texas
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: Générale de Santé - Hôpital Privé Saint Martin
city: Caen
country: France
facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Gabriel-Montpied
city: Dijon
country: France
facility: CHU de Dijon - Hospital Le Bocage
city: La Rochelle
country: France
facility: CHRU La Rochelle
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Pringy
country: France
facility: Centre hospitalier de la région d'Annecy
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire Saint Étienne
city: Villeurbanne
country: France
facility: Capio - Clinique du Tonkin
city: Athens
country: Greece
facility: Hygeia Hospital
city: Maroúsi
country: Greece
facility: Athens Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Castrovillari
country: Italy
facility: Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"
city: Lecce
country: Italy
facility: Ospedale "Vito Fazzi" Lecce
city: Milano
country: Italy
facility: Azienda Ospedaliera ospedale Niguarada ca Granda
city: Taranto
country: Italy
facility: Presidio Ospedaliero Centrale - SS.Annunziata
city: Udine
country: Italy
facility: Azienda ospedaleria Santa Maria dellaMisericordia di Udine
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira -Guimarães
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de SãoJoão Alameda
city: Santarém
country: Portugal
facility: Hospital Distrital de Santarém
city: Bratislava
country: Slovakia
facility: Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)
city: Coruna
country: Spain
facility: Hospital Universitario da coruna
city: Granda
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granda
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Complejo Universitario de Salamanca
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Zürich
country: Switzerland
facility: Cardiopark Zurich
city: Birmingham
country: United Kingdom
facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS - mancester Royal Infirmary
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital - SouthTees Hospitals NHS
city: Sheffield
country: United Kingdom
facility: Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera
Study officials:
References: