This trial is active, not recruiting.

Condition tachyarrhythmia
Sponsor Medtronic
Start date September 2015
End date December 2020
Trial size 10979 participants
Trial identifier NCT02849769, MR Tachy PAS


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

To characterize the proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.
time frame: up to 5 years post-approval.

Eligibility Criteria

Male or female participants of any age.

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. Exclusion Criteria:

Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic.