Paroxysmal Atrial Fibrillation, Sick Sinus Syndrome
Conditions
Keywords
AF, Automatic Mode Switch, FFRW, paroxysmal AF
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.
Interventions
DEVICEAccent Pacemaker
Implantation of pacemaker
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of undersensing of paroxysmal AF and AT from Holter recording. | 1-3 months |
Secondary
| Measure | Time frame |
|---|---|
| Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm. | 1-3 months |
Countries
Netherlands
Outcome results
None listed