OptiSense™ Performance in Detecting Atrial Episodes



Status:Completed
Conditions:Atrial Fibrillation, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:March 2009
End Date:September 2010

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OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

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 performance of the lead will be measured as a difference in device-determined
time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to
the control group which will be randomized to receive SJM's Tendril™ RA leads.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
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Akron, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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