Ventricular Tachycardia
Conditions
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.
Interventions
DEVICEIntrinsic Antitachycardia Pacing (iATP) Therapy
iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60% | Approximately 5 years | Demonstrating success rate of iATP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate the success rate of iATP in the FVT zone is greater than 70% | Approximately 5 years | Demonstrating success rate of iATP |
| To characterize arrhythmia-related syncope events | Approximately 5 years | characterizing arrhythmia-related syncope events |
| To characterize unnecessary and inappropriate shocks | Approximately 5 years | characterizing unnecessary and inappropriate shocks |
Countries
France, Greece, Italy, Portugal, Slovakia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed