Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent cerebral embolic events in patients with a high risk for embolic events, free from AF after successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score ≥2 after the first pulmonary vein ablation for paroxysmal AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
* Antral pulmonary vein ablation for patients with AF * left atrial fibrosis/electrical scar assessment by electroanatomical mapping * followed by 6 months OAC (3 months blanking period + 3 months observation period) * in case of AF-recurrence in month 4-6: re- pulmonary vein ablation * followed again by 6 months OAC (3 months blanking period + 3 months observation period) AF-free patients as assessed by 72h Holter ECG and symptoms wil be random-izedals to the following two interventional arms: * Experimental arm (group A): OAC with dabigatran for 12 months * Control arm (group B): No OAC (no placebo medication) for 12 months - Cerebral MRI at randomisation and 12 months later
Heart Center Freiburg University Bad Krozingen
Bad Krozingen, Germany
Heart Center Bad Neustadt-Saale
Bad Neustadt an der Saale, Germany
Bielefeld Clinical Centre
Bielefeld, Germany
Dept. of Medicine-Cardiology University Clinic Bonn
Bonn, Germany
University Hospital Cologne
Cologne, Germany
University Hospital Gießen
Giessen, Germany
University Hospital Göttingen
Göttingen, Germany
Hannover Medical School
Hanover, Germany
Westpfalz-Clinic GmbH Kaiserslautern
Kaiserslautern, Germany
Municipal Clinical Center Karlsruhe
Karlsruhe, Germany
...and 9 more locations
Incidence of new micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging 12 months after randomization compared to baseline MRI (3 months after AF catheter ablation)
Time frame: 12 months
Location, size and number of new micro- and macro-embolic lesions on cerebral MRI
Time frame: 12 months
Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism)
Time frame: 12 months
Severity of neurological deficits assessed by Modified Rankin Scale
Time frame: 12 months
Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism)
Time frame: 12 months
Life-threatening / major / minor bleedings
Time frame: 12 months
Hemorrhagic cerebral infarction
Time frame: 12 months
All-cause mortality / Cardiovascular mortality
Time frame: 12 months
Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF)
Time frame: 12 months
Correlation of cardio-embolic events with arrhythmia recurrence (atrial fi-brillation or atrial flutter post ablationem with ECG documentation or symp-toms)
Time frame: 12 months
Quality of life questionnaire (AF-specific symptoms, SF36)
Time frame: 12 months
Neuropsychological questionnaire (RBANS A&B)
Time frame: 12 months
Assessment of neurocognitive deficits: Minimental Test
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.