Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LivaNova
In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
A PR interval \<250ms AND
Documented atrial arrhythmia in the past year
Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
Patients must have less than two known cardioversions within the last year
Patient has signed a consent form after having received the appropriate information
You may not be if
Need a replacement pacemaker device
Have an unknown PR interval
Known AV block ≥ 250 ms PR interval
Minor and/or pregnant woman
Patients enrolled in other clinical trials
Patients with sustained ventricular arrhythmia
Patients with severe coronary artery disease (at the discretion of the investigator)
Patients with advanced cardiomyopathy (at the discretion of the investigator)
Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
Patients with unstable angina pectoris
Patients whose life expectancy is less than 1 year
Patients who are unlikely to return for required follow-up visits
Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
Patient unable to understand the purpose of the study or refusing to cooperate
Clareo Health | Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
