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SureScan Post-Approval Study

This study is currently recruiting participants.
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
History of Changes
  Purpose

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).


Condition
Bradycardia

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1810
Study Start Date: February 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299675

Contacts
Contact: SureScan PAS Study Team SureScan PAS Study Team 1-800-633-8766 medtroniccrmtrials@medtronic.com

  Show 63 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01299675     History of Changes
Other Study ID Numbers: SureScan PAS
Study First Received: February 16, 2011
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013