TY - JOUR
T1 - Rationale and design of VENTURE-AF
T2 - 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
AU - Naccarelli, Gerald V.
AU - Cappato, Riccardo
AU - Hohnloser, Stefan H.
AU - Marchlinski, Francis E.
AU - Wilber, David J.
AU - Xiang, Jim
AU - Ma, Changsheng
AU - Hess, Susanne
AU - Davies, David Wyn
AU - Fields, Larry E.
AU - Natale, Andrea
N1 - Funding Information:
This trial is funded by Johnson & Johnson and Bayer, and the authors are solely responsible for the design and conduct of this study and the drafting and editing of this paper and its final contents. An Executive Committee (EC) will oversee the conduct and reporting of the study. An independent blinded CEC will apply the protocol definitions and adjudicate and classify the following endpoints: bleeding events, MI, ischemic stroke, non-CNS systemic embolism, and death. In addition, procedure-attributable adverse events will be adjudicated and classified for the following events: procedure-attributable death, pericardial tamponade, stroke, TIA or systemic thromboembolism, atrio-esophageal fistula, pulmonary vein stenoses >50 % requiring intervention, groin complications, or other procedure-attributable bleeding or nonbleeding adverse events.
Funding Information:
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.
Publisher Copyright:
© 2014, Springer Science+Business Media New York.
PY - 2014/10/8
Y1 - 2014/10/8
N2 - Purpose: 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.Methods/design: 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.Relevance: This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation.
AB - Purpose: 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.Methods/design: 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.Relevance: This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation.
UR - https://www.scopus.com/pages/publications/84910155521
UR - https://www.scopus.com/pages/publications/84910155521#tab=citedBy
U2 - 10.1007/s10840-014-9924-9
DO - 10.1007/s10840-014-9924-9
M3 - Article
C2 - 25005452
AN - SCOPUS:84910155521
SN - 1383-875X
VL - 41
SP - 107
EP - 116
JO - Journal of Interventional Cardiac Electrophysiology
JF - Journal of Interventional Cardiac Electrophysiology
IS - 2
ER -