OptiSense™ Performance in Detecting Atrial Episodes

Completed

• Conditions: Atrial Fibrillation; Tachyarrhythmias
• Interventions: Device: Tendril Lead; Device: OptiSense Lead

• Registration Number: NCT00870324
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. Control	Tendril Lead	Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant
2. Experimental	OptiSense Lead	Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant

Primary Outcome Measures

Name	Time	Method
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).	3 months post-implant

Trial Locations

Locations (2)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Northeast Ohio Cardiovascular Specialists; 🇺🇸 Akron, Ohio, United States