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. Identifier: NCT01299675
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : April 27, 2018
Information provided by (Responsible Party):

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

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

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.

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 identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic 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:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes