OptiSense™ Performance in Detecting Atrial Episodes (SENSE-AF)

Abbott

Status: Completed

Conditions: Atrial Fibrillation; Tachyarrhythmias

Treatments: Device: OptiSense Lead; Device: Tendril Lead

Study type: Observational

Funder types: Industry

Identifiers

NCT00870324

CRD459

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

1. Control

Description:

Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant

Treatment:

Device: Tendril Lead

2. Experimental

Description:

Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant

Treatment:

Device: OptiSense Lead