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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Intrinsic Antitachycardia Pacing (iATP) Therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ICD/CRT device with iATP programmed on<br>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<br>* iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60% | Demonstrating success rate of iATP | Approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the success rate of iATP in the FVT zone is greater than 70% | Demonstrating success rate of iATP | Approximately 5 years | 
| To characterize arrhythmia-related syncope events | characterizing arrhythmia-related syncope events | Approximately 5 years | 
| To characterize unnecessary and inappropriate shocks | characterizing unnecessary and inappropriate shocks | Approximately 5 years |