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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||2483 participants|
|Actual Study Start Date :||February 8, 2011|
|Actual Primary Completion Date :||October 2, 2017|
|Actual Study Completion Date :||October 2, 2017|
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.
- MRI Related Complication Rate [ Time Frame: 5 years ]
- Lead Related Complication Rate [ Time Frame: 5 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299675