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

NCT ID: NCT04496518

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Intrinsic Antitachycardia Pacing (iATP) Therapy

Intervention Type DEVICE

iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intrinsic Antitachycardia Pacing (iATP) Therapy

iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Southwest EP

Chandler, Arizona, United States

Site Status

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas, United States

Site Status

Chula Vista Cardiac Center

Chula Vista, California, United States

Site Status

Cardiovascular Consultants Medical Group (Van Nuys CA)

Van Nuys, California, United States

Site Status

Cardiology Associates Medical Group

Ventura, California, United States

Site Status

Colorado Springs Cardiology

Colorado Springs, Colorado, United States

Site Status

Denver Heart

Denver, Colorado, United States

Site Status

Colorado Heart and Vascular, PC

Lakewood, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Heart Rhythm Solutions

Hollywood, Florida, United States

Site Status

Baptist Health

Jacksonville, Florida, United States

Site Status

Cardiovascular Institute of Northwest Florida

Panama City, Florida, United States

Site Status

Heart & Vascular Institute of Florida

Safety Harbor, Florida, United States

Site Status

Heart Rhythm Consultants P.A. (Sarasota Memorial Research)

Sarasota, Florida, United States

Site Status

Deaconess Specialty Physicians

Evansville, Indiana, United States

Site Status

Iowa Heart Center (West Des Moines IA)

Des Moines, Iowa, United States

Site Status

The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Norton Heart and Vascular Institute

Louisville, Kentucky, United States

Site Status

Tidal Health Peninsula Regional

Salisbury, Maryland, United States

Site Status

Associates in Cardiology PA

Silver Spring, Maryland, United States

Site Status

Brigham and Women's Hospital (Boston MA)

Boston, Massachusetts, United States

Site Status

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status

Michigan Heart

Ypsilanti, Michigan, United States

Site Status

Mayo Clinic (Rochester MN)

Rochester, Minnesota, United States

Site Status

Missouri Cardiovascular Specialists

Columbia, Missouri, United States

Site Status

University Hospital (Columbia MO)

Columbia, Missouri, United States

Site Status

Saint Lukes Health System

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Nebraska Medicine

Omaha, Nebraska, United States

Site Status

Monmouth Cardiology Associates

Ocean City, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

South Shore University Hospital

Bay Shore, New York, United States

Site Status

Huntington Hospital

Huntington, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Northern Westchester Hospital

Mount Kisco, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Site Status

NewYork-Presbyterian/Columbia University Irving Medical Center

New York, New York, United States

Site Status

Lenox Hill Hospital

New York, New York, United States

Site Status

Hudson Valley Heart Center

Poughkeepsie, New York, United States

Site Status

Staten Island University Hospital

Staten Island, New York, United States

Site Status

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Site Status

Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

Site Status

The Christ Hospital Health Network

Cincinati, Ohio, United States

Site Status

St Luke's University Health Network

Bethlehem, Pennsylvania, United States

Site Status

Saint Thomas Research Institute

Nashville, Tennessee, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

Heart Center of North Texas

Fort Worth, Texas, United States

Site Status

Consultants in Cardiology (Fort Worth TX)

Fort Worth, Texas, United States

Site Status

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Site Status

Clinique Rhône Durance

Avignon, , France

Site Status

CHU de Brest

Brest, , France

Site Status

Générale de Santé - Hôpital Privé Saint Martin

Caen, , France

Site Status

CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

Caen, , France

Site Status

CHU Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, , France

Site Status

CHU de Dijon - Hospital Le Bocage

Dijon, , France

Site Status

CHRU La Rochelle

La Rochelle, , France

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

Site Status

Centre hospitalier de la région d'Annecy

Pringy, , France

Site Status

Centre Hospitalier Universitaire Saint Étienne

Saint-Priest-en-Jarez, , France

Site Status

Capio - Clinique du Tonkin

Villeurbanne, , France

Site Status

Hygeia Hospital

Athens, , Greece

Site Status

Athens Medical Center

Marousi, , Greece

Site Status

Policlinico Sant' Orsola - Malpighi

Bologna, , Italy

Site Status

Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

Castrovillari, , Italy

Site Status

Ospedale "Vito Fazzi" Lecce

Lecce, , Italy

Site Status

Azienda Ospedaliera ospedale Niguarada ca Granda

Milan, , Italy

Site Status

Presidio Ospedaliero Centrale - SS.Annunziata

Taranto, , Italy

Site Status

Azienda ospedaleria Santa Maria dellaMisericordia di Udine

Udine, , Italy

Site Status

Hospital da Senhora da Oliveira -Guimarães

Guimarães, , Portugal

Site Status

Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE

Lisbon, , Portugal

Site Status

Centro Hospitalar Universitário de SãoJoão Alameda

Porto, , Portugal

Site Status

Hospital Distrital de Santarém

Santarém, , Portugal

Site Status

Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)

Bratislava, , Slovakia

Site Status

Hospital Universitario da coruna

A Coruña, , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granda, , Spain

Site Status

Hospital Universitario Clínico San Cecilio

Granda, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Complejo Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status

Cardiopark Zurich

Zurich, , Switzerland

Site Status

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital

Blackpool, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust Hammersmith Hospital

London, , United Kingdom

Site Status

Central Manchester University Hospitals NHS - mancester Royal Infirmary

Manchester, , United Kingdom

Site Status

The James Cook University Hospital - SouthTees Hospitals NHS

Middlesbrough, , United Kingdom

Site Status

Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States France Greece Italy Portugal Slovakia Spain Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

iATP PAS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ventricular Tachycardia Mechanisms
NCT05478213 RECRUITING NA
Ideal Pacer Pad Position Study
NCT03898050 COMPLETED NA
Therapy Cool Path Ablate VT
NCT00925522 TERMINATED NA