Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Tachyarrhythmia Clinical Trial

Official title:

Medtronic Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849769
• Other study ID #: MR Tachy PAS
• Status: Completed
• Start date: September 2015
• Est. completion date: May 2019

Study information

• Verified date: June 2019
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.

Description:

Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10979
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Related Conditions & MeSH terms

• Tachyarrhythmia
• Tachycardia

Intervention

Device:
• Implant of an MR-conditional Tachy device system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of episodes with = 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.	The primary objective will be analyzed and reported when 50 patients with a true VF episode following MR exposure have been identified	up to 5 years post-approval.
Secondary	The number of patients with 2 or more scans	The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode.	up to 5 years post-approval
Secondary	Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink	Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements	up to 5 years post-approval