OptiSense™ Performance in Detecting Atrial Episodes

Completed

Conditions studied: Tachyarrhythmias, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00870324

Run by

Abbott Medical Devices

People needed

50

Starts

2009-03-01

Expected to finish

2010-09-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Northeast Ohio Cardiovascular Specialists — Akron, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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