This trial is active, not recruiting.

Condition tachyarrhythmia
Sponsor Biotronik, Inc.
Start date August 2016
End date May 2021
Trial size 8437 participants
Trial identifier NCT02933619, ProMRI PAS


Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
time frame: Up to 5 years post-approval
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.
time frame: Up to 5 years post-approval

Secondary Outcomes

Workflow compliance following MR exposure
time frame: Up to 5 years post-approval
Left ventricular sensing attenuation
time frame: Up to 5 years post-approval

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring. Exclusion Criteria:

Additional Information

Official title ProMRI ICD/CRT-D Post Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biotronik, Inc..