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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
Sponsor:
Information provided by (Responsible Party):
Medtronic

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).


Condition or disease Intervention/treatment
Ventricular Tachycardia Device: Intrinsic Antitachycardia Pacing (iATP) Therapy

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. To characterize arrhythmia-related syncope events [ Time Frame: Approximately 5 years ]
    characterizing arrhythmia-related syncope events

  3. To characterize unnecessary and inappropriate shocks [ Time Frame: Approximately 5 years ]
    characterizing unnecessary and inappropriate shocks



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients providing informed consent to participate prior to or within 30 days of implant of an iATP-capable cardiac rhythm device with iATP on in at least one zone. Patients need to be enrolled in Medtronic's CareLink network for remote device monitoring.
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

Information from the National Library of Medicine

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


Contacts
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Contact: iATP PAS Study Manager 1-800-633-8766 rs.productsurveillanceregistry@medtronic.com

Locations
Show Show 57 study locations
Sponsors and Collaborators
Medtronic
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT04496518    
Other Study ID Numbers: iATP PAS
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes