OptiSense™ Performance in Detecting Atrial Episodes

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.