AzTrials
AzTrials

Ventricular TachycardiaNCT04496518

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

An observational study of Ventricular Tachycardia, run by Medtronic at 92 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Ventricular Tachycardia
What is being tested?
Intrinsic Antitachycardia Pacing (iATP) Therapy
Type of treatment
Medical device
How many people
2,200 participants
Where
92 sitesin 9 countries
Study dates
1 Aug 2020to 31 Jan 2028
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 9 countries.

92 sites in 9 countries

United States51 sites

  • Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304-1473

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106-4921

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705-1852

  • South Shore University Hospital

    Bay Shore, New York, 11706

  • St Luke's University Health Network

    Bethlehem, Pennsylvania, 18015-1000

  • Brigham and Women's Hospital (Boston MA)

    Boston, Massachusetts, 02115-6110

  • Southwest EP

    Chandler, Arizona, 85226

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910

  • The Christ Hospital Health Network

    Cincinati, Ohio, 45219

  • Colorado Springs Cardiology

    Colorado Springs, Colorado, 80907

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201-8023

  • University Hospital (Columbia MO)

    Columbia, Missouri, 65201

  • Denver Heart

    Denver, Colorado, 80220

  • Iowa Heart Center (West Des Moines IA)

    Des Moines, Iowa, 50266

  • Deaconess Specialty Physicians

    Evansville, Indiana, 47710

  • Heart Center of North Texas

    Fort Worth, Texas, 761014

  • Consultants in Cardiology (Fort Worth TX)

    Fort Worth, Texas, 76104

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Heart Rhythm Solutions

    Hollywood, Florida, 33021-3552

  • Huntington Hospital

    Huntington, New York, 11743

  • Baptist Health

    Jacksonville, Florida, 32207-8208

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160-8500

  • Saint Lukes Health System

    Kansas City, Missouri, 64111-5934

  • Colorado Heart and Vascular, PC

    Lakewood, Colorado, 80228

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Saint Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205-6202

  • Norton Heart and Vascular Institute

    Louisville, Kentucky, 40205

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215-3678

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37205-2018

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021

  • NewYork-Presbyterian/Columbia University Irving Medical Center

    New York, New York, 10032

  • Lenox Hill Hospital

    New York, New York, 10075

  • Monmouth Cardiology Associates

    Ocean City, New Jersey, 07712-4764

  • Nebraska Medicine

    Omaha, Nebraska, 68105

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601-3923

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610

  • Mayo Clinic (Rochester MN)

    Rochester, Minnesota, 55902-1906

  • Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695-6604

  • Tidal Health Peninsula Regional

    Salisbury, Maryland, 21801

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

    Sarasota, Florida, 34233

  • Associates in Cardiology PA

    Silver Spring, Maryland, 20910-1265

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

  • Staten Island University Hospital

    Staten Island, New York, 10305-3436

  • Cardiovascular Consultants Medical Group (Van Nuys CA)

    Van Nuys, California, 91405

  • Cardiology Associates Medical Group

    Ventura, California, 93003

  • Michigan Heart

    Ypsilanti, Michigan, 48197-8633

Other trials in United States

France11 sites

  • Clinique Rhône Durance

    Avignon, 84082

  • CHU de Brest

    Brest, 29609

  • Générale de Santé - Hôpital Privé Saint Martin

    Caen, 14000

  • CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

    Caen, 14033

  • CHU Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand, 63003

  • CHU de Dijon - Hospital Le Bocage

    Dijon, 21079

  • CHRU La Rochelle

    La Rochelle, 17019

  • Nouvelles Cliniques Nantaises

    Nantes, 44277

  • Centre hospitalier de la région d'Annecy

    Pringy, 74374

  • Centre Hospitalier Universitaire Saint Étienne

    Saint-Priest-en-Jarez, 42270

  • Capio - Clinique du Tonkin

    Villeurbanne, 69100

Other trials in France

Spain8 sites

  • Hospital Universitario da coruna

    A Coruña, 15006

  • Hospital Universitario Virgen de las Nieves

    Granda, 18014

  • Hospital Universitario Clínico San Cecilio

    Granda, 18016

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Complejo Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago, 15706

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47006

Other trials in Spain

United Kingdom7 sites

  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham, B15 2GW

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

    Blackpool, FY3 8NR

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE

  • Imperial College Healthcare NHS Trust Hammersmith Hospital

    London, W12 0HS

  • Central Manchester University Hospitals NHS - mancester Royal Infirmary

    Manchester, M13 9WL

  • The James Cook University Hospital - SouthTees Hospitals NHS

    Middlesbrough, TS4 3BW

  • Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera

    Sheffield, S5 7AU

Other trials in United Kingdom

Italy6 sites

  • Policlinico Sant' Orsola - Malpighi

    Bologna, 40138

  • Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

    Castrovillari, 87012

  • Ospedale "Vito Fazzi" Lecce

    Lecce, 73100

  • Azienda Ospedaliera ospedale Niguarada ca Granda

    Milan, 20162

  • Presidio Ospedaliero Centrale - SS.Annunziata

    Taranto, 74024

  • Azienda ospedaleria Santa Maria dellaMisericordia di Udine

    Udine, 33100

Other trials in Italy

Portugal4 sites

  • Hospital da Senhora da Oliveira -Guimarães

    Guimarães, 4835-044

  • Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE

    Lisbon, 1649-035

  • Centro Hospitalar Universitário de SãoJoão Alameda

    Porto, 4200-319

  • Hospital Distrital de Santarém

    Santarém, 2000-177

Other trials in Portugal

Greece2 sites

  • Hygeia Hospital

    Athens, 15123

  • Athens Medical Center

    Marousi, 15125

Other trials in Greece

Switzerland2 sites

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

  • Cardiopark Zurich

    Zurich, 8027

Other trials in Switzerland

Slovakia1 site

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

    Bratislava

Other trials in Slovakia

About this study

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).

Read the 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.

Being tested
Intrinsic Antitachycardia Pacing (iATP) Therapy
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrinsic Antitachycardia Pacing (iATP) TherapyDevice

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

Study groups in NCT04496518
Study groupRoleWhat they receive
Patients with ICD/CRT device with iATP programmed onPatients 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.
Receives: Device: Intrinsic Antitachycardia Pacing (iATP) Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%

    Demonstrating success rate of iATP

    Measured: Approximately 5 years

Secondary outcomes (3)

  1. To demonstrate the success rate of iATP in the FVT zone is greater than 70%

    Demonstrating success rate of iATP

    Measured: Approximately 5 years

  2. To characterize arrhythmia-related syncope events

    characterizing arrhythmia-related syncope events

    Measured: Approximately 5 years

  3. To characterize unnecessary and inappropriate shocks

    characterizing unnecessary and inappropriate shocks

    Measured: Approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2020
  2. Study start1 Aug 2020
  3. Primary completion6 Nov 2024
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,200 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496518
Sponsor's protocol ID
iATP PAS
Status last verified
Oct 2025
First submitted
29 Jul 2020
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail. 2025 May;31(5):824-832. doi: 10.1016/j.cardfail.2024.11.011. Epub 2024 Dec 16.

    PubMed 39694452

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Tachycardia, run by Medtronic at 92 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, France, Spain, United Kingdom, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60% (time frame: Approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04496518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT04496518 | AzTrials