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 |
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.
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.
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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