CompletedNot Applicable

OptiSense™ Performance in Detecting Atrial Episodes

United States50 participantsStarted 2009-03

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).

Timeframe: 3 months post-implant

Trial details

NCT IDNCT00870324

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Tachyarrhythmias trials