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 |
The purpose of this post approval study is to characterize the chronic performance of the
SJM Optisure family of HV leads in patients.
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
Newtown, Pennsylvania 18940
Principal Investigator: Michael Rozengarten, Dr.
Phone: 215-741-5600
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
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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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
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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Birmingham, Alabama 35211
Principal Investigator: Ibrahim Hanna, Dr.
Phone: 205-780-4330
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Burbank, California 91505
Principal Investigator: Raymond Schaerf, Dr.
Phone: 818-843-2334
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El Paso, Texas 79902
Principal Investigator: Juan Taveras, Dr.
Phone: 915-542-2352
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Fredericksburg, Virginia 22401
Principal Investigator: Ashok Talreja, Dr.
Phone: 540-741-4655
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
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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Haddon Heights, New Jersey 08035
Principal Investigator: Steven DaTorre, Dr.
Phone: 856-358-2363
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High Point, North Carolina
Principal Investigator: David Fitzgerald, Dr.
Phone: 336-885-6168
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Jackson, Mississippi 39216
Principal Investigator: Judson Colley, Dr.
Phone: 601-982-7850
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555 N Duke St
Lancaster, Pennsylvania 17602
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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Leominster, Massachusetts 01453
Principal Investigator: Dionyssios Robotis, Dr.
Phone: 978-534-3179
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Liverpool, New York 13088
Principal Investigator: Albert Nayeri, Dr.
Phone: 315-701-2170
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Milwaukee, Wisconsin 14450
Principal Investigator: Mohamed Djelmami-Hani, Dr.
Phone: 414-385-2849
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Minneapolis, Minnesota 55407
Principal Investigator: JoEllyn Abraham, Dr.
Phone: 612-863-9291
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Northridge, California 91325
Principal Investigator: Leo Polosajian, Dr.
Phone: 818-718-1600
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Oklahoma City, Oklahoma
Principal Investigator: Terrance Khastgir, Dr.
Phone: 405-951-2894
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Phoenix, Arizona
Principal Investigator: Ashish Sadhu, Dr.
Phone: 602-628-8595
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Rockford, Illinois 61107
Principal Investigator: Farhad Farokhi, Dr.
Phone: 815-847-5835
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Saint George, Utah 84790
Principal Investigator: Kent Gleed, Dr.
Phone: 435-251-2905
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Salisbury, Maryland 21804
Principal Investigator: Emmanuel Nsah, Dr.
Phone: 410-749-0821
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Traverse City, Michigan 49684
Principal Investigator: Naomi Overton, Dr.
Phone: 231-487-9185
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Tupelo, Mississippi 38801
Principal Investigator: Keith Kyker, Dr.
Phone: 662-620-6853
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Voorhees Township, New Jersey 08043
Principal Investigator: Darius Sholevar, Dr.
Phone: 856-673-1346
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West Des Moines, Iowa 50266
Principal Investigator: Denise Sorrentino, Dr.
Phone: 515-633-3844
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Winnipeg, Manitoba
Principal Investigator: Colette Seifer, Dr.
Phone: 204-235-3826
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