Status:
COMPLETED
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradycardia
Sick Sinus Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three f...
Eligibility Criteria
Inclusion
- Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.
Exclusion
- Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR \> 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
903 Patients enrolled
Trial Details
Trial ID
NCT00286858
Start Date
September 1 2006
End Date
December 1 2010
Last Update
January 28 2021
Active Locations (40)
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1
CHRU- Hôpital Nord
Amiens, France, 80054
2
Clinique Cardiologique Aressy
Aressy, France, 64320
3
Clinique du Lac et d'Argonay
Argonay, France, 74370
4
CH d'Arles
Arles, France, 13200