Status:
COMPLETED
OptiSense™ Performance in Detecting Atrial Episodes
Lead Sponsor:
Abbott Medical Devices
Conditions:
Tachyarrhythmias
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The per...
Eligibility Criteria
Inclusion
- Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
- Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant
Exclusion
- Patients with a history of Permanent or Persistent AF
- Patient's life expectancy is less than 12 months.
- Patient is pregnant.
- Patient's age at enrollment is less than 18 years.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00870324
Start Date
March 1 2009
End Date
September 1 2010
Last Update
February 4 2019
Active Locations (2)
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1
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States, 44304
2
The Ohio State University
Columbus, Ohio, United States, 43210