title: 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.
abstract: OBJECTIVE
  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
  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.
  
  
  CONCLUSIONS
  This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation.
authors.affiliation: Heart and Vascular Institute, Penn State University College of Medicine, P. O. Box 850, MC H047, 500 University Drive, Room H1511, Hershey, PA, 17033, USA, gnaccarelli@hmc.psu.edu.
authors.forename: Gerald V
authors.initials: GV
authors.lastname: Naccarelli
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cappato
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.forename: Francis E
authors.initials: FE
authors.lastname: Marchlinski
authors.forename: David J
authors.initials: DJ
authors.lastname: Wilber
authors.forename: Jim
authors.initials: J
authors.lastname: Xiang
authors.forename: Changsheng
authors.initials: C
authors.lastname: Ma
authors.forename: Susanne
authors.initials: S
authors.lastname: Hess
authors.forename: David Wyn
authors.initials: DW
authors.lastname: Davies
authors.forename: Larry E
authors.initials: LE
authors.lastname: Fields
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D061214:Patient Safety; D011182:Postoperative Care; D011300:Preoperative Care; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000209:etiology / Q000517:prevention & control; D000069552:Rivaroxaban; D018709:Statistics, Nonparametric; D015996:Survival Rate; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000209:etiology / Q000517:prevention & control; D014812:Vitamin K / Q000008:administration & dosage / Q000037:antagonists & inhibitors*; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D009025:Morpholines; D013876:Thiophenes; D014812:Vitamin K; D014859:Warfarin; D000069552:Rivaroxaban