Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2009-03-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1. Control
Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant
Tendril Lead
The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead.
2. Experimental
Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant
OptiSense Lead
The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead.
Interventions
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OptiSense Lead
The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead.
Tendril Lead
The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead.
Eligibility Criteria
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Inclusion Criteria
* Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant
Exclusion Criteria
* Patient's life expectancy is less than 12 months.
* Patient is pregnant.
* Patient's age at enrollment is less than 18 years.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Countries
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Other Identifiers
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CRD459
Identifier Type: -
Identifier Source: org_study_id
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