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SureScan Post-Approval Study

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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

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.

Condition or disease
Bradycardia

Study Type : Observational
Actual Enrollment : 2483 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : February 8, 2011
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : October 2, 2017

Group/Cohort
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.



Primary Outcome Measures :
  1. MRI Related Complication Rate [ Time Frame: 5 years ]
  2. Lead Related Complication Rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Assess change in pacing thresholds after multiple MRI scans [ Time Frame: 5 years ]
  2. Summarize MRI system and scan conditions [ Time Frame: 5 years ]
  3. Pacing system related events [ Time Frame: 5 years ]
  4. Characterize lead impedance [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for or implanted with a Medtronic SureScan Pacing System. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
Criteria

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

Information from the National Library of Medicine

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


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Sponsors and Collaborators
Medtronic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01299675     History of Changes
Other Study ID Numbers: SureScan PAS
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by Medtronic:
MR conditional

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes