Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
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- STATUS
- Recruiting
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- End date
- Jan 31, 2027
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- participants needed
- 2200
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- sponsor
- Medtronic
Micra Registry Manager
Primary Contact
MedStar Health Research Institute (Baltimore) (7.6 mi away) Contact
+45 other locationSummary
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 Identifier | NCT04496518 |
| Sponsor | Medtronic |
| Last Modified on | 15 January 2021 |
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