SureScan Post-Approval Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/29/2018
Start Date:February 8, 2011
End Date:October 2, 2017

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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.


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
We found this trial at
60
sites
108
mi
from 43215
Elyria, OH
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110
mi
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Akron, OH
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1333
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Albuquerque, NM
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436
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from 43215
Atlanta, GA
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1980
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Bakersfield, CA
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405
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Bethlehem, PA
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862
mi
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Bradenton, FL
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1949
mi
from 43215
Chula Vista, CA
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98
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from 43215
Cincinnati, OH
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830
mi
from 43215
Clearwater, FL
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127
mi
from 43215
Cleveland, OH
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Colorado Springs, Colorado 80910
1161
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from 43215
Colorado Springs, CO
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6
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Columbus, OH
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634
mi
from 43215
Coon Rapids, MN
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910
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from 43215
Dallas, TX
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354
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from 43215
Durham, NC
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2098
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from 43215
East Palo Alto, CA
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212
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from 43215
Erie, PA
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280
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from 43215
Evansville, IN
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320
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from 43215
Falls Church, VA
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437
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from 43215
Florence, SC
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970
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from 43215
Fort Lauderdale, FL
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1134
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from 43215
Fort Sam Houston, TX
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937
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from 43215
Fort Worth, TX
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1993
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from 43215
Fresno, CA
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1968
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from 43215
Glendale, CA
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1751
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Henderson, NV
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304
mi
from 43215
Hickory, NC
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508
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from 43215
Huntington, NY
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620
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from 43215
Kansas City, KS
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618
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from 43215
Kansas City, MO
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446
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from 43215
Kingston,
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353
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from 43215
Lancaster, PA
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622
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from 43215
Little Rock, AR
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1975
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from 43215
Long Beach, CA
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1972
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from 43215
Los Angeles, CA
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188
mi
from 43215
Louisville, KY
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504
mi
from 43215
Marquette, MI
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335
mi
from 43215
Milwaukee, WI
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331
mi
from 43215
Nashville, TN
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537
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from 43215
New Haven, CT
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481
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from 43215
New York, NY
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371
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from 43215
Raleigh, NC
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630
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from 43215
Robbinsdale, MN
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627
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from 43215
Saint Louis Park, MN
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617
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Saint Paul, MN
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2090
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Salinas, CA
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411
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from 43215
Salisbury, MD
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1144
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San Antonio, TX
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2107
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Santa Rosa, CA
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327
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from 43215
Takoma Park, MD
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121
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Toledo, OH
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1983
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Torrance, CA
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181
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Troy, MI
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274
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from 43215
Urbana, IL
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1981
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Van Nuys, CA
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572
mi
from 43215
West Des Moines, IA
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465
mi
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West Orange, NJ
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306
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from 43215
Winston-Salem, NC
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373
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from 43215
Wyomissing, PA
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