Van Nuys, California 91405

  • Ventricular Tachycardia

Purpose:

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).


Study summary:

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.


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


NCT ID:

NCT04496518


Primary Contact:

iATP PAS Study Manager
Phone: 1-800-633-8766
Email: rs.productsurveillanceregistry@medtronic.com


Backup Contact:

N/A


Location Contact:

Van Nuys, California 91405
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 15, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.