Status:
COMPLETED
Spontaneous Atrio Ventricular Conduction Preservation
Lead Sponsor:
LivaNova
Conditions:
Sinus Node Dysfunction
Bradycardia-Tachycardia Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode. In addition to saving ener...
Eligibility Criteria
Inclusion
- Patient has been primo-implanted with a Symphony™ 2550 or 2450 devices for less than 3 months
- Patient with a normal spontaneous AV conduction at rest (PR \< 250 ms)
- Patient implanted for Sinus Node Dysfunction, Braycardia-Tachycardia Syndrome, carotid sinus syndrome/ vaso vagal syndrome or paroxistic AV Block
- Patient implanted with a bipolar right-atrial lead and ventricular lead available in the local market
- Patient has signed a consent form after having received the appropriate information
Exclusion
- Permanent 1st, 2nd or 3rd AV block
- Patient having a medical status complying with one of the following cases
- patient suffering from sustained ventricular arrhythmias
- patient having sustained a myocardial infarction within the last month
- patient having undergone cardiac surgery within the last month
- patient suffering from severe aortic stenosis
- patient suffering from unstable angina pectoris
- patient presents with permanent atrial arrhythmias
- Patient is not able to understand the study objectives and protocol or refuses to co-operate
- Patient is not available for scheduled follow-up
- Patient has a life expectancy less than one year
- Patient is included into another clinical study
- Patient is minor or a pregnant woman
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT00655213
Start Date
November 1 2003
End Date
December 1 2006
Last Update
April 9 2008
Active Locations (67)
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1
Onze lieve Vrouw ziekenhuis
Aalst, Belgium
2
Clinique Louis Caty
Baudour, Belgium
3
Hôpital universitaire Brugmann
Brussels, Belgium
4
Europa ziekenhuis
Campus Saint Elisabeth Uccle, Belgium