Clinical Trial: Optimal Sensing in Atrial Tachyarrhythmia's Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study

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 Summary: 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.
Sponsor: St. Jude Medical

Current Primary Outcome: Number of undersensing of paroxysmal AF and AT from Holter recording. [ Time Frame: 1-3 months ]

Original Primary Outcome: Number of undersensing of paroxysmal AF and AT from Holter recording. [ Time Frame: 2-4 months ]

Current Secondary Outcome: Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm. [ Time Frame: 1-3 months ]

Original Secondary Outcome: Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm. [ Time Frame: 2-4 months ]

Information By: St. Jude Medical

Dates:
Date Received: February 22, 2010
Date Started: July 2010
Date Completion:
Last Updated: July 7, 2015
Last Verified: July 2015