Optimal Sensing in Atrial Tachyarrhythmia's Study

Paroxysmal Atrial Fibrillation Clinical Trial

— OSAT  

Official title:

OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01074749
• Other study ID #: CR-09-058-ND-LV
• Status: Terminated
• Phase: N/A
• Start date: July 2010
• Est. completion date: July 2014

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Sick Sinus Syndrome
• Tachycardia

Intervention

Device:
• Accent Pacemaker
Implantation of pacemaker

Locations

Country	Name	City	State
Netherlands	Lucas Andreas Ziekenhuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of undersensing of paroxysmal AF and AT from Holter recording.		1-3 months
Secondary	Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.		1-3 months