SureScan Post-Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01299675
First received: February 16, 2011
Last updated: February 19, 2013
Last verified: February 2013

February 16, 2011
February 19, 2013
February 2011
November 2018   (final data collection date for primary outcome measure)
  • MRI Related Complication Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Lead Related Complication Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01299675 on ClinicalTrials.gov Archive Site
  • Assess change in pacing thresholds after multiple MRI scans [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Summarize MRI system and scan conditions [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pacing system related events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Characterize lead impedance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
SureScan Post-Approval Study
Not Provided

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. This study is part of the Product Performance Platform (PPP).

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients indicated for or implanted with a Medtronic SureScan Pacing System. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Bradycardia
Not Provided
  • Chronic Performance Arm
    Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months.
  • Multiple MRI Scan Arm
    Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic's standard of care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1810
November 2018
November 2018   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: SureScan PAS Study Team SureScan PAS Study Team 1-800-633-8766 medtroniccrmtrials@medtronic.com
United States,   Canada
 
NCT01299675
SureScan PAS
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Not Provided
Medtronic Cardiac Rhythm Disease Management
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP