Optimal Sensing in Atrial Tachyarrhythmia's Study

Not Applicable

Terminated

• Conditions: Paroxysmal Atrial Fibrillation; Sick Sinus Syndrome
• Interventions: Device: Accent Pacemaker

• Registration Number: NCT01074749
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2010-07
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optisense lead	Accent Pacemaker	Patients with an Accent pacemaker and an OptiSense atrial lead
Tendril lead	Accent Pacemaker	Patients with an Accent pacemaker and a Tendril atrial lead

Primary Outcome Measures

Name	Time	Method
Number of undersensing of paroxysmal AF and AT from Holter recording.	1-3 months

Secondary Outcome Measures

Name	Time	Method
Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.	1-3 months

Trial Locations

Locations (1)

Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Netherlands