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Clinical Trials/NCT01299675
NCT01299675CompletedNot Applicable

SureScan Post-Approval Study

Medtronic0 sites2,483 target enrollmentStarted: February 8, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Medtronic
Enrollment
2,483
Primary Endpoint
MRI Related Complication Rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • •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
  • •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

  • •Subject who is, or will be inaccessible for follow-up
  • •Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
  • •Subject with exclusion criteria required by local law

Outcomes

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(5 years)
  • Summarize MRI system and scan conditions(5 years)
  • Pacing system related events(5 years)
  • Characterize lead impedance(5 years)

Investigators

Sponsor
Medtronic
Sponsor Class
Industry
Responsible Party
Sponsor

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