Optimal Sensing in Atrial Tachyarrhythmia's Study
Not Applicable
Terminated
- Conditions
- Paroxysmal Atrial FibrillationSick Sinus Syndrome
- 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.
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
- 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
Lucas Andreas Ziekenhuis🇳🇱Amsterdam, Netherlands