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Clinical Trial Summary

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.


Clinical Trial Description

This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03786640
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date October 4, 2019
Completion date December 18, 2021

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