SureScan Pacing System Post-Approval Study (SureScan PAS)

Study ID
STU 102011-053

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital—St. Paul

Contact
Dana Red
214-590-5015
dana.red@utsouthwestern.edu

Principal Investigator
James Daniels

Summary

The SureScan Pacing System PAS is a global, non-randomized, multi-center study. Subjects will be enrolled into either the Chronic Performance Arm or Multiple MRI Scan Arm. Subjects are eligible for enrollment into one arm of the study and will remain in the arm they are enrolled throughout their participation in the study. Data from subjects enrolled in the Chronic Performance Arm Subjects will also contribute to the Multiple MRI Scn analysis. Subjects who participated in the EnRhythm MRI IDE study are eligible for enrollment into the Multiple MRI Scan Arm only.

Participant Eligibility

1) Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
2) Subject is intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
3) Subject within 30 days of implant (maximum 50% of prospective enrollment) or subject retrospectively enrolled (>30days post implant) with existing MRI indication.