Right Atrial Pacing versus Left Atrial Pacing to Prevent Development of Paroxysmal Atrial Fibrillation in Patients with Sick Sinus Syndrome or Anti-arrhythmic Drug-induced Bradycardia.
Completed
- Conditions
- incidental atrial fibrillationParoxysmal atrial fibrillation1000752110007593
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
- Written informed consent signed by patient
- Sick Sinus Syndrome or anti-arrhythmic drug-induced bradycardia
- Documented paroxysmal atrial fibrillation with a duration of >= 30 seconds in the past 6
months
- 18 years old or older
Exclusion Criteria
- Life expectancy of <= 5 years
- Left Ventricular Ejection Fraction of <= 40 percent
- Congenital Heart Defects
- Mentally unable to participate in the follow up protocol
- Physically unable to participate in the follow up protocol
- Malignancies
- Chronic Obstructive Pulmonary Disease (COPD)
- GFR value of <= 30 mL/min or Creatinine value of >= 250 umol/l
- Participation in another investigational drug or device study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint of this study is development of paroxysmal atrial fibrillation<br /><br>despite left or right atrial stimulation.<br /><br>The follow up period is 36 months. At specific time intervals patient will be<br /><br>called by the investigator in order to check whether atrial fibrillation has<br /><br>occurred. Patients atrial rhythm will continuously be monitored by Home<br /><br>Monitoring® supplied by the pacemaker manufacturer.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of Life assessment will be performed at specific time intervals.</p><br>