OptiSense™ Performance in Detecting Atrial Episodes

Atrial Fibrillation Clinical Trial

— SENSE-AF  

Official title:

OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870324
• Other study ID #: CRD459
• Status: Completed
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Tachyarrhythmias
• Tachycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Northeast Ohio Cardiovascular Specialists	Akron	Ohio
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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