OptiSense™ Performance in Detecting Atrial Episodes

OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00870324

Acronym

SENSE-AF

Enrollment

Registered

2009-03-27

Start date

2009-03-31

Completion date

2010-09-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Tachyarrhythmias

Keywords

ICD, Tachyarrhythmias, Atrial Fibrillation, Patients who meets current ICD or CRT-D implant indications

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.

Interventions

DEVICEOptiSense 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.

DEVICETendril 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026