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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04496518




Registration number
NCT04496518
Ethics application status
Date submitted
29/07/2020
Date registered
3/08/2020
Date last updated
30/08/2023

Titles & IDs
Public title
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Scientific title
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Secondary ID [1] 0 0
iATP PAS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Intrinsic Antitachycardia Pacing (iATP) Therapy

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.


Treatment: Devices: Intrinsic Antitachycardia Pacing (iATP) Therapy
iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
To demonstrate the success rate of iATP in the FVT zone is greater than 70%
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
To characterize arrhythmia-related syncope events
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
To characterize unnecessary and inappropriate shocks
Timepoint [3] 0 0
Approximately 5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Washington
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Wisconsin
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France
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Avignon
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Bayonne
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Brest
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Caen
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Clermont-Ferrand
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France
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Dijon
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France
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La Rochelle
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Nantes
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Pringy
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France
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Saint-Priest-en-Jarez
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France
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Villeurbanne
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Athens
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Greece
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Maroúsi
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Italy
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Bologna
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Italy
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Castrovillari
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Italy
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Lecce
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Italy
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Milano
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Italy
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Taranto
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Italy
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Udine
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Portugal
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Guimarães
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Portugal
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Lisbon
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Portugal
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Porto
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Portugal
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Santarém
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Slovakia
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Bratislava
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Coruna
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Granda
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Madrid
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Salamanca
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Santiago
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Spain
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Tenerife
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Valladolid
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Switzerland
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Geneva
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Switzerland
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Zürich
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United Kingdom
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Birmingham
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Blackpool
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Liverpool
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London
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Manchester
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Middlesbrough
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United Kingdom
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04496518
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
iATP PAS Study Manager
Address 0 0
Country 0 0
Phone 0 0
1-800-633-8766
Fax 0 0
Email 0 0
rs.productsurveillanceregistry@medtronic.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04496518