This trial is active, not recruiting.

Condition bradycardia
Sponsor Medtronic
Start date February 2011
End date July 2018
Trial size 1810 participants
Trial identifier NCT01299675, SureScan PAS


The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months.
Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care.

Primary Outcomes

MRI Related Complication Rate
time frame: 5 years
Lead Related Complication Rate
time frame: 5 years

Secondary Outcomes

Assess change in pacing thresholds after multiple MRI scans
time frame: 5 years
Summarize MRI system and scan conditions
time frame: 5 years
Pacing system related events
time frame: 5 years
Characterize lead impedance
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements 2. Subject is or 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 Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication Exclusion Criteria: 1. Subject who is, or will be inaccessible for follow-up 2. Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable 3. Subject with exclusion criteria required by local law

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Medtronic.