OptiSense™ Performance in Detecting Atrial Episodes

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.

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Key information

Conditions

Tachyarrhythmias Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northeast Ohio Cardiovascular Specialists, Akron, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OptiSense Lead

Device

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

Device

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.

Primary outcomes

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).

Time frame: 3 months post-implant

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

Acronym: SENSE-AF

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Mar 27, 2009
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed