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

Use our guide to learn which trials are right for you!

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
?
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
East Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Elyria, OH
Click here to add this to my saved trials
?
mi
from
Erie, PA
Click here to add this to my saved trials
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
?
mi
from
Florence, SC
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Glendale, CA
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Huntington, NY
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Kingston,
Click here to add this to my saved trials
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Marquette, MI
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Robbinsdale, MN
Click here to add this to my saved trials
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
?
mi
from
Salinas, CA
Click here to add this to my saved trials
?
mi
from
Salisbury, MD
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
?
mi
from
Takoma Park, MD
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Urbana, IL
Click here to add this to my saved trials
?
mi
from
Van Nuys, CA
Click here to add this to my saved trials
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
?
mi
from
West Orange, NJ
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials