Safety of Rivaroxaban in patients with nonvalvular atrial fibrillation who undergo catheter ablation

A Randomized, Open-label, Active-controlled Multi-center Study to Evaluate the Safety of Rivaroxaban and Vitamin K Antagonists in Subjects Undergoing Catheter Ablation for Atrial Fibrillation - VENTURE-AF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001484-79-DE

Enrollment

250

Registered

2012-10-16

Start date

2013-02-06

Completion date

Unknown

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo catheter ablation MedDRA version: 16.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Xarelto Product Name: Rivaroxaban Product Code: BAY 59-7939 (JNJ-39039039) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Have a documented history of paroxysmal (lasting 1 week and =65 years) yes F.1.3.1 Number of subjects for this age range 103

Exclusion criteria

Exclusion criteria: • Has contraindications to the use of anticoagulant therapy (eg, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy or a platelet count 5 x upper limit of normal [ULN] or ALT >3 x ULN plus total bilirubin >2 x ULN using laboratory values from the screening period). (12.1 -Criterion modified per amendment)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult subjects with nonvalvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.;Secondary Objective: The secondary objective is to evaluate the thromboembolism profile of rivaroxaban and uninterrupted VKA as measured by the composite and the individual components of the following post procedure events: myocardial infarction (MI), ischemic stroke, non-CNS systemic embolism, and vascular death.;Primary end point(s): The primary endpoint for this study is the incidence of post-procedure major bleeding events observed within the first 30 ± 5 days after the catheter ablation procedure;Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)	—

Measure

Time frame

Main Objective: The primary objective is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult subjects with nonvalvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.;Secondary Objective: The secondary objective is to evaluate the thromboembolism profile of rivaroxaban and uninterrupted VKA as measured by the composite and the individual components of the following post procedure events: myocardial infarction (MI), ischemic stroke, non-CNS systemic embolism, and vascular death.;Primary end point(s): The primary endpoint for this study is the incidence of post-procedure major bleeding events observed within the first 30 ± 5 days after the catheter ablation procedure;Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints for this study include: • Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death. • Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the individual components of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death.;Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)	—

Measure

Time frame

Secondary end point(s): The secondary endpoints for this study include: • Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death. • Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the individual components of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death.;Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)

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Countries

Belgium, France, Germany, United Kingdom, United States

Contacts

Public ContactLarry Fields

Janssen Scientific Affairs

lfields@its.jnj.com0119089274124

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026