Optisure Lead Post Approval Study



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2014
End Date:July 2021
Contact:Linda Saberi
Email:lsaberi@sjm.com

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The purpose of this post approval study is to characterize the chronic performance of the
SJM Optisure family of HV leads in patients.


Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of
an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular
tachyarrhythmia(s).

2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are
scheduled for an Optisure lead implant.

3. Have the ability to provide informed consent for study participation and be willing
and able to comply with the prescribed follow-up tests and schedule of evaluations.

4. Are 18 years or above, or of legal age to give informed consent specific to state and
national law.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Enrolled or intend to participate in a clinical drug and/or device study, which could
confound the results of this trial as determined by SJM, during the course of this
clinical study.

2. Have a life expectancy of less than 5 years due to any condition.
We found this trial at
29
sites
Winnipeg, Manitoba
Principal Investigator: Colette Seifer, Dr.
Phone: 204-235-3826
1521
mi
from 91732
Winnipeg,
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Principal Investigator: Gregory Altemose, Dr.
Phone: 610-402-9543
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
2356
mi
from 91732
Allentown, PA
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Cesar Cruz, Dr.
Phone: 404-357-8676
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
1918
mi
from 91732
Atlanta, GA
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Bedford, Texas 76021
Principal Investigator: Michael Delaughter, Dr.
Phone: 682-223-9120
1205
mi
from 91732
Bedford, TX
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Birmingham, Alabama 35211
Principal Investigator: Ibrahim Hanna, Dr.
Phone: 205-780-4330
1783
mi
from 91732
Birmingham, AL
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Burbank, California 91505
Principal Investigator: Raymond Schaerf, Dr.
Phone: 818-843-2334
18
mi
from 91732
Burbank, CA
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El Paso, Texas 79902
Principal Investigator: Juan Taveras, Dr.
Phone: 915-542-2352
686
mi
from 91732
El Paso, TX
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Fredericksburg, Virginia 22401
Principal Investigator: Ashok Talreja, Dr.
Phone: 540-741-4655
2261
mi
from 91732
Fredericksburg, VA
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
Principal Investigator: Matthew Ebinger, Dr.
Phone: 810-606-7550
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
1941
mi
from 91732
Grand Blanc, MI
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Haddon Heights, New Jersey 08035
Principal Investigator: Steven DaTorre, Dr.
Phone: 856-358-2363
2381
mi
from 91732
Haddon Heights, NJ
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High Point, North Carolina
Principal Investigator: David Fitzgerald, Dr.
Phone: 336-885-6168
2141
mi
from 91732
High Point, NC
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Jackson, Mississippi 39216
Principal Investigator: Judson Colley, Dr.
Phone: 601-982-7850
1609
mi
from 91732
Jackson, MS
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Lake Mary, Florida 32746
Principal Investigator: Jorge Diaz, Dr.
Phone: 407-444-4848
2180
mi
from 91732
Lake Mary, FL
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Matthew Bernabei, Dr.
Phone: 717-544-1777
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
2313
mi
from 91732
Lancaster, PA
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Leominster, Massachusetts 01453
Principal Investigator: Dionyssios Robotis, Dr.
Phone: 978-534-3179
2542
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from 91732
Leominster, MA
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Liverpool, New York 13088
Principal Investigator: Albert Nayeri, Dr.
Phone: 315-701-2170
2315
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from 91732
Liverpool, NY
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Milwaukee, Wisconsin 14450
Principal Investigator: Mohamed Djelmami-Hani, Dr.
Phone: 414-385-2849
1729
mi
from 91732
Milwaukee, WI
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Minneapolis, Minnesota 55407
Principal Investigator: JoEllyn Abraham, Dr.
Phone: 612-863-9291
1509
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from 91732
Minneapolis, MN
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Newtown, Pennsylvania 18940
Principal Investigator: Michael Rozengarten, Dr.
Phone: 215-741-5600
2386
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from 91732
Newtown, PA
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Northridge, California 91325
Principal Investigator: Leo Polosajian, Dr.
Phone: 818-718-1600
30
mi
from 91732
Northridge, CA
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Oklahoma City, Oklahoma
Principal Investigator: Terrance Khastgir, Dr.
Phone: 405-951-2894
1164
mi
from 91732
Oklahoma City, OK
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Phoenix, Arizona
Principal Investigator: Ashish Sadhu, Dr.
Phone: 602-628-8595
343
mi
from 91732
Phoenix, AZ
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Rockford, Illinois 61107
Principal Investigator: Farhad Farokhi, Dr.
Phone: 815-847-5835
1662
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from 91732
Rockford, IL
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Saint George, Utah 84790
Principal Investigator: Kent Gleed, Dr.
Phone: 435-251-2905
324
mi
from 91732
Saint George, UT
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Salisbury, Maryland 21804
Principal Investigator: Emmanuel Nsah, Dr.
Phone: 410-749-0821
2361
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from 91732
Salisbury, MD
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Traverse City, Michigan 49684
Principal Investigator: Naomi Overton, Dr.
Phone: 231-487-9185
1864
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from 91732
Traverse City, MI
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Tupelo, Mississippi 38801
Principal Investigator: Keith Kyker, Dr.
Phone: 662-620-6853
1666
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from 91732
Tupelo, MS
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Voorhees Township, New Jersey 08043
Principal Investigator: Darius Sholevar, Dr.
Phone: 856-673-1346
2386
mi
from 91732
Voorhees Township, NJ
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West Des Moines, Iowa 50266
Principal Investigator: Denise Sorrentino, Dr.
Phone: 515-633-3844
1414
mi
from 91732
West Des Moines, IA
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