Clinical Research Details

Clinical Research

SJM Brady MRI (Magnetic Resonance Imaging) Post Approval Study (PAS)

Study Description

This study will evaluate the long term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI pacemaker such as Accent MRI™, Assurity MRI™, Endurity MRI™, or similar model in subjects with a standard bradycardia pacing (slow heart rate) indication. Additionally, the study will look at how the SJM Brady MRI system works after it has undergone an MRI scan.

FDA is now allowing your study doctor to perform MRI Scans because your implanted pacemaker system is now MRI Conditional. This means you may undergo MRI scans with your implanted SJM Brady MRI system because you have the Tendril MRI lead implanted with a SJM MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ or similar model. If you decide to take part in the MRI Scan visit portion of this research study, you will be asked a series of questions about whether or not you’ve had any MRI scans in the past and other relevant information that will help your doctor determine if you qualify for the MRI Scan visit portion the study. Based on your answers and your medical history, your doctor will decide if you qualify to participate in the MRI Scan visit portion of the study.

Open Enrollment

Contact Name: Andrea Goosen
Contact Phone: (904) 244-4660
Contact Email: Andrea.Goosen@jax.ufl.edu

Investigators


Principal Investigator
John N. Catanzaro, M.D., FACC, FESC, FHRS
Medicine