Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Tachycardia
- Sponsor
- Medtronic
- Enrollment
- 2200
- Locations
- 92
- Primary Endpoint
- To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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).
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%
Time Frame: Approximately 5 years
Demonstrating success rate of iATP
Secondary Outcomes
- To characterize arrhythmia-related syncope events(Approximately 5 years)
- To demonstrate the success rate of iATP in the FVT zone is greater than 70%(Approximately 5 years)
- To characterize unnecessary and inappropriate shocks(Approximately 5 years)