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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Trial Summary
Trial Overview
Inclusion Criteria
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
Lancaster General Hospital
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...
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Lancaster, PA
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Lehigh Valley Hospital
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...
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Allentown, PA
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Northside Hospital
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...
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Atlanta, GA
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HeartPlace
Bedford, Texas 76021
Principal Investigator: Michael Delaughter, Dr.
Phone: 682-223-9120
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Bedford, TX
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Baptist Medical Center - Princeton
Birmingham, Alabama 35211
Principal Investigator: Ibrahim Hanna, Dr.
Phone: 205-780-4330
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Birmingham, AL
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Raymond Schaerf, MD
Burbank, California 91505
Principal Investigator: Raymond Schaerf, Dr.
Phone: 818-843-2334
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Burbank, CA
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Cardiology Care Consultants
El Paso, Texas 79902
Principal Investigator: Juan Taveras, Dr.
Phone: 915-542-2352
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El Paso, TX
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Mary Washington Hospital
Fredericksburg, Virginia 22401
Principal Investigator: Ashok Talreja, Dr.
Phone: 540-741-4655
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Fredericksburg, VA
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Genesys Regional Medical Center
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...
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Grand Blanc, MI
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Cardiovascular Associates of the Delaware Valley, PA
Haddon Heights, New Jersey 08035
Principal Investigator: Steven DaTorre, Dr.
Phone: 856-358-2363
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Haddon Heights, NJ
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Carolina Cardiology Cornerstone
High Point, North Carolina
Principal Investigator: David Fitzgerald, Dr.
Phone: 336-885-6168
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High Point, NC
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Jackson Heart Clinic
Jackson, Mississippi 39216
Principal Investigator: Judson Colley, Dr.
Phone: 601-982-7850
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Jackson, MS
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Jorge Diaz
Lake Mary, Florida 32746
Principal Investigator: Jorge Diaz, Dr.
Phone: 407-444-4848
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Lake Mary, FL
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Mass Heart and Rhythm
Leominster, Massachusetts 01453
Principal Investigator: Dionyssios Robotis, Dr.
Phone: 978-534-3179
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Leominster, MA
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Cardiovascular Group of Syracuse
Liverpool, New York 13088
Principal Investigator: Albert Nayeri, Dr.
Phone: 315-701-2170
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Liverpool, NY
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Aurora Medical Group
Milwaukee, Wisconsin 14450
Principal Investigator: Mohamed Djelmami-Hani, Dr.
Phone: 414-385-2849
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Milwaukee, WI
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Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Principal Investigator: JoEllyn Abraham, Dr.
Phone: 612-863-9291
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Minneapolis, MN
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Arrhythmia Institute
Newtown, Pennsylvania 18940
Principal Investigator: Michael Rozengarten, Dr.
Phone: 215-741-5600
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Newtown, PA
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Cardiac Rhythm Specialists, Inc.
Northridge, California 91325
Principal Investigator: Leo Polosajian, Dr.
Phone: 818-718-1600
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Northridge, CA
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Integris Baptist Medical Center
Oklahoma City, Oklahoma
Principal Investigator: Terrance Khastgir, Dr.
Phone: 405-951-2894
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Oklahoma City, OK
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Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona
Principal Investigator: Ashish Sadhu, Dr.
Phone: 602-628-8595
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Phoenix, AZ
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Rockford Cardiology Associates
Rockford, Illinois 61107
Principal Investigator: Farhad Farokhi, Dr.
Phone: 815-847-5835
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Rockford, IL
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Dixie Regional Medical Center - River Road Campus
Saint George, Utah 84790
Principal Investigator: Kent Gleed, Dr.
Phone: 435-251-2905
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Saint George, UT
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Peninsula Cardiology Associates
Salisbury, Maryland 21804
Principal Investigator: Emmanuel Nsah, Dr.
Phone: 410-749-0821
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Salisbury, MD
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Northern Michigan Hospital
Traverse City, Michigan 49684
Principal Investigator: Naomi Overton, Dr.
Phone: 231-487-9185
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Traverse City, MI
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Cardiology Associates of North Mississippi, PA
Tupelo, Mississippi 38801
Principal Investigator: Keith Kyker, Dr.
Phone: 662-620-6853
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Tupelo, MS
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Lourdes Cardiology Services
Voorhees Township, New Jersey 08043
Principal Investigator: Darius Sholevar, Dr.
Phone: 856-673-1346
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Voorhees Township, NJ
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Iowa Heart Center, P.C.
West Des Moines, Iowa 50266
Principal Investigator: Denise Sorrentino, Dr.
Phone: 515-633-3844
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West Des Moines, IA
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St. Boniface General Hospital
Winnipeg, Manitoba
Principal Investigator: Colette Seifer, Dr.
Phone: 204-235-3826
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Winnipeg,
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