Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
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|ClinicalTrials.gov Identifier: NCT04496518|
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : May 12, 2021
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 or disease||Intervention/treatment|
|Ventricular Tachycardia||Device: Intrinsic Antitachycardia Pacing (iATP) Therapy|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2200 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||January 31, 2025|
|Estimated Study Completion Date :||January 31, 2027|
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).
- 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
- To demonstrate the success rate of iATP in the FVT zone is greater than 70% [ Time Frame: Approximately 5 years ]Demonstrating success rate of iATP
- To characterize arrhythmia-related syncope events [ Time Frame: Approximately 5 years ]characterizing arrhythmia-related syncope events
- To characterize unnecessary and inappropriate shocks [ Time Frame: Approximately 5 years ]characterizing unnecessary and inappropriate shocks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496518
|Contact: iATP PAS Study Manageremail@example.com|