Optimal Sensing in Atrial Tachyarrhythmia's Study (OSAT)

Abbott

Status: Terminated

Conditions: Paroxysmal Atrial Fibrillation; Sick Sinus Syndrome

Treatments: Device: Accent Pacemaker

Study type: Interventional

Funder types: Industry

Identifiers

NCT01074749

CR-09-058-ND-LV

Details and patient eligibility

About

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).

Full description

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
• Signed informed consent
• Age >18 yrs

Exclusion criteria

• Severe valvular heart disease (echocardiogram less than 6 months old)
• Angina Pectoris class ≥ III
• Congestive heart failure - NYHA class ≥ III
• Left Ventricular Ejection Fraction < 35% (less than 6 months old)
• Hypertrophic Cardiomyopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 2 patient groups

Optisense lead

Active Comparator group

Description:

Patients with an Accent pacemaker and an OptiSense atrial lead

Treatment:

Device: Accent Pacemaker

Tendril lead

Active Comparator group

Description:

Patients with an Accent pacemaker and a Tendril atrial lead

Treatment:

Device: Accent Pacemaker