NCT00870324

OptiSense™ Performance in Detecting Atrial Episodes

OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tachyarrhythmias
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	OptiSense Lead	The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead.
DEVICE	Tendril Lead	The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-03-27
• Last updated: 2019-02-04

Locations

2 sites across 1 country: United States