To evaluate the safety of uninterrupted rivaroxaban, a novel oral anticoagulant that directly inhibits factor Xa, and a vitamin K antagonist (VKA) in eligible adult patients with nonvalvular AF (NVAF) who are scheduled for a catheter ablation.
This is a prospective, randomized, open-label, active-controlled, global multicenter safety study of up to 250 randomized patients. Eligible patients with paroxysmal or persistent NVAF, a left ventricular ejection fraction >40 %, and a creatinine clearance >50 mL/min will be randomized 1:1 to rivaroxaban 20 mg orally once daily or to dose-adjusted oral VKA (recommended international normalized ratio (INR) 2.0–3.0) and stabilized on anticoagulation therapy for 1–7 days (if no intracardiac thrombus on transesophageal echocardiogram (TEE) immediately prerandomization/post-randomization or if 3 weeks of sufficient anticoagulation is documented) or for 4–5 weeks (if no TEE, no documented 3 weeks of sufficient anticoagulation, or by patient choice). During catheter ablation, heparin will be administered (ACT-targeted range = 300–400 s) after catheter ablation, and VKA will be managed per usual care. The next dose of rivaroxaban will be provided at least 6 h after establishment of hemostasis. The primary endpoint will be the incidence of post-procedure major bleeding events observed during the first 30 ± 5 days post-ablation. Secondary endpoints will include post-procedure thromboembolic events, additional bleeding, time-to-event, and medication adherence.
This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation.
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Clinical Endpoint Committee
Central nervous system
Deep vein thrombosis
Food and Drug Administration
Global Use of Strategies to Open Occluded Coronary Arteries
International normalized ratio
International Society on Thrombosis and Haemostasis
Low molecular weight heparin
Nonvalvular atrial fibrillation
Partial thromboplastin time
Transient ischemic attack
Thrombolysis in Myocardial Infarction
Vitamin K antagonist
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Members of the Steering Committee thank participating patients, VENTURE-AF Investigators, and their teams for patient identification, enrollment, care and reporting, past and present members of the VENTURE-AF Core Integrated Team at Johnson & Johnson and Bayer, and Johnson & Johnson and Bayer for sponsorship of this study. Thanks also to C. V. Damaraju, PhD for initial expert statistical support.
Conflict of interest
All authors received research grant support from the sponsors of the trial (Johnson & Johnson and Bayer). Gerald V. Naccarelli, MD, FACC, FHRS is a consultant for Glaxo-Smith-Kline, Pfizer, Xention, Sanofi, Bristol Myers Squibb, Merck, Biosense-Webster, Janssen, Otsuka, Daiichi-Sankyo, and Boehringer Ingelheim. Riccardo Cappato, MD, FESC: Biosense Webster, St Jude Medical, and Bard. StefanH. Hohnloser, MD, FACC, FESC, FHRS: consulting and lecture fees from Boehringer Ingelheim, BMS, Bayer, Pfizer, and Sanofi-aventis. Francis E. Marchlinski, MD, FACC: no further disclosures. David J. Wilber, MD, FAHA, FACC, FHRS: lectures and consulting fees from Biosense Webster, Medtronic, St Jude, Cardioinsight and research support from Biosense Webster, Medtronic. Changsheng Ma, MD, FHRS: no further disclosures. David Wyn Davies MD, FRCP, FHRS: consultant for Boston Scientific, Janssen, Medtronic and Rhythmia. Andrea Natale MD, FACC, FHRS, FESC: Biosense Webster, Boston Scientific, Janssen, St. Jude Medical, Medtronic and Biotronik. Larry E. Fields, MD, FAHA, FACC: is an employee of Johnson & Johnson at Janssen Scientific Affairs, LLC. Jim Xiang, PhD: is an employee of Johnson & Johnson at Janssen Research & Development, LLC. Susanne Hess, MD: is an employee of Bayer.
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Naccarelli, G.V., Cappato, R., Hohnloser, S.H. et al. Rationale and design of VENTURE-AF: a randomized, open-label, active-controlled multicenter study to evaluate the safety of rivaroxaban and vitamin K antagonists in subjects undergoing catheter ablation for atrial fibrillation. J Interv Card Electrophysiol 41, 107–116 (2014). https://doi.org/10.1007/s10840-014-9924-9
- Atrial fibrillation
- Catheter ablation
- Vitamin K antagonist