Status:
COMPLETED
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Lead Sponsor:
Dr. Kai Jaquet
Collaborating Sponsors:
Abbott Medical Devices
Hansen Medical
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.
Eligibility Criteria
Inclusion
- paroxysmal atrial fibrillation
- persistent atrial fibrillation \< 2 month
- indication for catheter ablation
- LEF \> 50%
- diameter LA \< 50 mm
Exclusion
- intracardial thrombus
- atrial fibrillation with underlying curable disease
- renal failure \> stage I
- contraindication for anticoagulation
- life expectancy \< 12 month
- previous PVI
- pregnancy
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2018
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00982475
Start Date
September 1 2009
End Date
February 27 2018
Last Update
March 7 2018
Active Locations (1)
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1
ASKLEPIOS KLINIK St. Georg
Hamburg, Germany, 20099