ClinicalTrials.gov
ClinicalTrials.gov Menu

SureScan Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01299675
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic

February 16, 2011
February 18, 2011
April 27, 2018
February 8, 2011
October 2, 2017   (Final data collection date for primary outcome measure)
  • MRI Related Complication Rate [ Time Frame: 5 years ]
  • Lead Related Complication Rate [ Time Frame: 5 years ]
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 ]
  • 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 ]
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.
Not Provided
Observational
Observational Model: Cohort
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
    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 Characterization
    Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care.
Williamson BD, Gohn DC, Ramza BM, Singh B, Zhong Y, Li S, Shanahan L; SureScan Post-Approval Study Investigators. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients. JACC Clin Electrophysiol. 2017 Nov;3(11):1231-1239. doi: 10.1016/j.jacep.2017.05.011. Epub 2017 Sep 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2483
1810
October 2, 2017
October 2, 2017   (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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01299675
SureScan PAS
No
Not Provided
Not Provided
Medtronic
Medtronic
Not Provided
Not Provided
Medtronic
April 2018