SureScan Post-Approval Study

NCT01299675 | Completed

• 1 other identifier: SureScan PAS
• Study Type: observational
• Target: 2,483
• Locations: 2 countries
• Sites: 61

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.

Conditions

Bradycardia

Keywords

MR conditional

Outcome Measures

Primary Outcomes (2)

• MRI Related Complication Rate

  5 years

• Lead Related Complication Rate

  5 years

Secondary Outcomes (4)

• Assess change in pacing thresholds after multiple MRI scans

  5 years

• Summarize MRI system and scan conditions

  5 years

• Pacing system related events

  5 years

• Characterize lead impedance

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• 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
• 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

You may not qualify if:

• Subject who is, or will be inaccessible for follow-up
• Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable

Sponsors & Collaborators

• Medtronic: lead

Study Sites (61)

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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East Palo Alto, California, United States

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Fresno, California, United States

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Glendale, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Salinas, California, United States

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Santa Rosa, California, United States

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Torrance, California, United States

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Van Nuys, California, United States

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Colorado Springs, Colorado, United States

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New Haven, Connecticut, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Atlanta, Georgia, United States

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Urbana, Illinois, United States

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Evansville, Indiana, United States

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West Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Marquette, Michigan, United States

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Troy, Michigan, United States

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Coon Rapids, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Saint Paul, Minnesota, United States

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Kansas City, Missouri, United States

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Henderson, Nevada, United States

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West Orange, New Jersey, United States

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Albuquerque, New Mexico, United States

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Huntington, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Elyria, Ohio, United States

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Toledo, Ohio, United States

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Bethlehem, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Florence, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Sam Houston, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Milwaukee, Wisconsin, United States

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Kingston, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Related Publications (1)

• Williamson BD, Gohn DC, Ramza BM, Singh B, Zhong Y, Li S, Shanahan L; SureScan Post-Approval Study Investigators. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients. JACC Clin Electrophysiol. 2017 Nov;3(11):1231-1239. doi: 10.1016/j.jacep.2017.05.011. Epub 2017 Sep 13.

  PMID: 29759618 DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: February 8, 2011
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

CA (2); US (59)