OVATIO CRT and SITUS OTW LV Lead Post Approval Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:December 2008
Contact:Gwen Gimmestad
Email:gwen.gimmestad@sorin.com
Phone:763-519-9465

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Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over
5 years.


Inclusion Criteria:

- NYHA Class III/IV

- Stable medical regimen

- QRS greater than or equal to 130 ms

- LVEF less than or equal to 35%

Exclusion Criteria:

- VT of transient or reversible causes

- Incessant VT

- Currently implanted with a lead positioned through the coronary sinus (unless it is
the SITUS OTW LV lead)

- Cardiac revascularization or angioplasty within the last month

- Heart failure due to correctable valve disease

- Chronic, medially refractory AT

- Enrolled in another clinical study that may confound the results of this study

- Life expectancy less than 6 months

- Inability to understand the purpose of the study or refusal to cooperate

- Inability or refusal to provide informed consent

- Unavailable for scheduled follow-up with the implanting practice

- Sensitivity to 1 mg dexamethasone sodium phosphate

- Less than 18 years of age

- Pregnancy
We found this trial at
33
sites
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Ayer, Massachusetts 01432
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Encino, California 91436
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Guttenberg, New Jersey 07093
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Lancaster, Pennsylvania 17604
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Los Angeles, California 90067
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Macon, Georgia 31201
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Mesa, Arizona 85201
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Miami Beach, Florida 33140
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New Orleans, Louisiana 70121
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Newburyport, Massachusetts 01950
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Tarzana, California 91356
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Toledo, Ohio 43623
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Tulsa, Oklahoma 74136
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Victorville, California 92395
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Wilmington, Delaware 19958
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