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Trial record 2 of 9 for:    surescan

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 : Active, not recruiting
First Posted : February 18, 2011
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Observational
Estimated Enrollment : 1810 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : November 2018
Groups and Cohorts

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.


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
Contacts and Locations

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
More Information

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: March 23, 2017
Last Verified: March 2017

Keywords provided by Medtronic:
MR conditional

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