Atrial Fibrillation Clinical Trial
Official title:
Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
| Verified date | March 2018 |
| Source | Asklepios proresearch |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | February 27, 2018 |
| Est. primary completion date | February 27, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | ASKLEPIOS KLINIK St. Georg | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Kai Jaquet | Hansen Medical, St. Jude Medical |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Freedom of AF 12 months after procedure. | 12 month |
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