SureScan Post-Approval Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management Identifier:
First received: February 16, 2011
Last updated: October 6, 2014
Last verified: October 2014

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

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)
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.


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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01299675

  Hide Study Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Bakersfield, California, United States
Chula Vista, California, United States
East Palo Alto, California, United States
Fresno, California, United States
Glendale, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Salinas, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Van Nuys, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Bradenton, Florida, United States
Clearwater, Florida, United States
Fort Lauderdale, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Urbana, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
United States, Iowa
West Des Moines, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maryland
Salisbury, Maryland, United States
Takoma Park, Maryland, United States
United States, Michigan
Marquette, Michigan, United States
Troy, Michigan, United States
United States, Minnesota
Coon Rapids, Minnesota, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Nevada
Henderson, Nevada, United States
United States, New Jersey
West Orange, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Huntington, New York, United States
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Elyria, Ohio, United States
Toledo, Ohio, United States
United States, Pennsylvania
Bethlehem, Pennsylvania, United States
Erie, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
United States, South Carolina
Florence, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Fort Sam Houston, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Falls Church, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Canada, Ontario
Kingston, Ontario, Canada
Canada, Quebec
Trois-Rivieres, Quebec, Canada
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management Identifier: NCT01299675     History of Changes
Other Study ID Numbers: SureScan PAS
Study First Received: February 16, 2011
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
MR conditional

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on October 06, 2015