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SJM Brady MRI Post Approval Study

IRB Protocol #: 1704018115

ClinicalTrials.gov Identifier: NCT03170583

 

Overview: The purpose of this study is to evaluate the long term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with the Accent MRI™ pacemaker or similar model such as Assurity MRI™, Endurity MRI™, together known as the SJM Brady MRI system. Additionally, the study will look at how the SJM Brady MRI system works after it has undergone an MRI scan.

This trial is funded by St. Jude Medical.

 

To be eligible, patients must meet one of the following criteria:

  • Subject who will be implanted with at least one Tendril MRI™ lead with a MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ (or similar model).
  • Subject who is implanted with at least one Tendril MRI lead with a MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ (or similar model) and is being rolled over after being previously enrolled in the Accent MRI IDE study.
  • Subject who is implanted with at least one Tendril MRI lead with a MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ (or similar model) but is not enrolled in Accent MRI IDE study.

 

Patients cannot participate if they have:

  • Been enrolled or intend to participate in another clinical trial
  • Another health condition that prevents them from completing all routine study visits

 

Contact:

Dr. Steven Markowitz
Principle Investigator
Email: Smarkow@med.cornell.edu
Phone: (212) 746-2158

 

Grace Lee
Research Coordinator
Email: Grl2008@med.cornell.edu
Phone: (646) 962-8493

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