Summary

Healthy Volunteers
healthy people welcome
Location
at Chula Vista, California and other locations
Dates
study started
estimated completion

Description

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).

Details

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.

Keywords

Ventricular Tachycardia Tachycardia Tachycardia, Ventricular Intrinsic Antitachycardia Pacing (iATP) Therapy

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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

Locations

  • Chula Vista Cardiac Center not yet accepting patients
    Chula Vista California 91910 United States
  • COR Healthcare not yet accepting patients
    Torrance California 90505 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic
ID
NCT04496518
Study Type
Observational [Patient Registry]
Last Updated