Persistent Atrial Fibrillation Clinical Trial
Official title:
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Verified date | November 2016 |
Source | Cardioangiologisches Centrum Bethanien |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.
Status | Completed |
Enrollment | 152 |
Est. completion date | November 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 18 to 80 years - persistent atrial fibrillation - failure of at least one antiarrhythmic drug - others Exclusion Criteria: - contraindications for pulmonary vein isolation (PVI) - previous PVI attempts - inability to be treated with oral anticoagulation - presence of intracardiac thrombi - pregnancy - others |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | Na Homolce Hospital | Prague | |
Germany | Herz- und Gefäß-Klinik GmbH Bad Neustadt | Bad Neustadt | Bavaria |
Germany | Rheinische Friedrich-Wilhelms-Universität Bonn | Bonn | NRW |
Germany | Cardioangiologisches Centrum Bethanien | Frankfurt/Main | |
Germany | Städtisches Klinikum Karlsruhe, Medizinische Klinik IV | Karlsruhe | |
Spain | Hospital Universitari i Politecnic La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Boris Schmidt |
Czech Republic, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds | between day 90 and 365 days after index procedure | No |
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