non-valvular atrial fibrillation and pulmonary vein ablation
Conditions
Interventions
Treatment with dabigatran etexilate instead of VKA.
Ablation
anticoagulation
Dabigatran
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Male or female patients aged >
Exclusion criteria
Exclusion criteria: - Patients with permanent AF. - Patients with AF felt to be secondary to an obvious reversible cause. - Patients with LA size >= 60 mm - Patients with contraindications to systemic anticoagulation with heparin, warfarin or dabigatran etexilate - Patients with a known allergy to warfarin tablets and it excipients or to dabigatran etexilate or its excipients - Mechanical or biological heart valve prosthesis - Severe renal impairment - Stroke within 1 month prior to screening visit - Major surgery per investigator judgement within the previous month prior to screening. - Patient has received an organ transplant or is on a waiting list for an organ transplant - History of intracranial haemorrhage, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding - Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated (e.g. by surgery). - Major bleeding episode (ISTH definition) one month prior to the screening visit. - Haemorrhagic disorder or bleeding diathesis - Anaemia or thrombocytopenia including heparin-induced thrombocytopenia at screening - Recent malignancy or radiation therapy (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this trial is a safety endpoint: * The incidence of Major Bleeding Events according to the ISTH definition during the ablation procedure and up to 2 months post-ablation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints for this trial are the incidence of the following efficacy and safety endpoints: *- Stroke/SE/TIA events during the ablation procedure and up to 2 months post-ablation. *- Minor bleeding events during the ablation procedure and up to 2 months postablation. *- A composite of major bleeding events and thromboembolic events (Stroke, SE and TIA) during the ablation procedure and up to 2 months post-ablation. | — |
Countries
Belgium, Canada, France, Germany, Ireland, Italy, Japan, Netherlands, Spain, United Kingdom, United States of America
Outcome results
None listed