Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

PHASE4CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

September 15, 2020

Study Completion Date

September 15, 2020

Conditions
Atrial FibrillationCardioembolic EventsOral Anticoagulation
Interventions
DRUG

Dabigatran

"* 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"

Trial Locations (19)

30625

Hannover Medical School, Hanover

33604

Bielefeld Clinical Centre, Bielefeld

35392

University Hospital Gießen, Giessen

37075

University Hospital Göttingen, Göttingen

42117

Helios Hospital, Wuppertal

50937

University Hospital Cologne, Cologne

58515

Hospital Lüdenscheid, Lüdenscheid

67063

Ludwigshafen Hospital, Ludwigshafen

67655

Westpfalz-Clinic GmbH Kaiserslautern, Kaiserslautern

68167

University Hospital Mannheim, Mannheim

72076

University Hospital Tübingen, Tübingen

76133

Municipal Clinical Center Karlsruhe, Karlsruhe

76137

St. Vincentius Hospital, Karlsruhe

78050

Schwarzwald-Baar Hospital Villingen Schwenningen, Villingen-Schwenningen

79189

Heart Center Freiburg University Bad Krozingen, Bad Krozingen

81379

Peter Osypka Heart Center, Munich

97616

Heart Center Bad Neustadt-Saale, Bad Neustadt an der Saale

D-53105

Dept. of Medicine-Cardiology University Clinic Bonn, Bonn

04289

Heart Center Leipzig, Leipzig

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

Georg Nickenig

OTHER