Clinical trial NCT01299675: SureScan Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Keywords: MR conditional
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 2483
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: MRI Related Complication Rate
timeFrame: 5 years
measure: Lead Related Complication Rate
timeFrame: 5 years
Secondary outcomes:
measure: Assess change in pacing thresholds after multiple MRI scans
timeFrame: 5 years
measure: Summarize MRI system and scan conditions
timeFrame: 5 years
measure: Pacing system related events
timeFrame: 5 years
measure: Characterize lead impedance
timeFrame: 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: East Palo Alto
country: United States
state: California
city: Fresno
country: United States
state: California
city: Glendale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Salinas
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Urbana
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Salisbury
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Marquette
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Coon Rapids
country: United States
state: Minnesota
city: Robbinsdale
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: West Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Huntington
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Elyria
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Bethlehem
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Kingston
country: Canada
state: Ontario
city: Trois-Rivieres
country: Canada
state: Quebec
Study officials:
References:
citation: 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.