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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2027
  • participants needed
    2200
  • sponsor
    Medtronic
Updated on 15 January 2021
Investigator
Micra Registry Manager
Primary Contact
MedStar Health Research Institute (Baltimore) (7.6 mi away) Contact
+45 other location
antitachycardia pacing

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).

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.

Details
Treatment Intrinsic Antitachycardia Pacing (iATP) Therapy
Clinical Study IdentifierNCT04496518
SponsorMedtronic
Last Modified on15 January 2021

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Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Fast Heart Rate (Tachycardia) or Ventricular tachycardia or Tachycardia?
Do you have any of these conditions: Tachycardia or Ventricular tachycardia or Fast Heart Rate (Tachycardia)?
Do you have any of these conditions: Fast Heart Rate (Tachycardia) or Tachycardia or Ventricular tachycardia?
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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