NCT00982475CompletedNot Applicable
Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Dr. Kai Jaquet1 site in 1 country130 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Freedom of AF 12 months after procedure.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •paroxysmal atrial fibrillation
- •persistent atrial fibrillation < 2 month
- •indication for catheter ablation
- •LEF > 50%
- •diameter LA < 50 mm
Exclusion Criteria
- •intracardial thrombus
- •atrial fibrillation with underlying curable disease
- •renal failure > stage I
- •contraindication for anticoagulation
- •life expectancy < 12 month
- •previous PVI
- •pregnancy
Arms & Interventions
PVI with robotic navigation
Active Comparator
Intervention: Pulmonary vein isolation with radiofrequency current (Procedure)
PVI manually
Placebo Comparator
Intervention: Pulmonary vein isolation with radiofrequency current (Procedure)
Outcomes
Primary Outcomes
Freedom of AF 12 months after procedure.
Time Frame: 12 month
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Kai Jaquet
Prof. Dr. Roland Richard Tilz
Asklepios proresearch
Study Sites (1)
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