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).

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Intrinsic Antitachycardia Pacing (iATP) Therapy
    iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).

Recruiting Locations

The University of Kansas Medical Center
Kansas City, Kansas 66160-8500
Contact:
Site Coordinator
913-588-9679

More Details

Status
Recruiting
Sponsor
Medtronic

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.