A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Collaborator: Bayer
• Treatments: Rivaroxaban; Vitamin K; Vitamins

Criteria

Inclusion Criteria:

• Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation (NVAF);

• Have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (>=1 year) NVAF;

• Be suitable for anticoagulant therapy and catheter ablation as per the judgment of the investigator;

• Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active;

• Women of childbearing potential must have a negative serum pregnancy test at screening;

• Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol;

• Have a life expectancy of at least 6 months

Exclusion Criteria:

• Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive status epilepticus within 6 months of the screening visit;

• Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure;

• Has had major surgery (requiring general anesthesia), within 6 months before screening or planned surgery during the time the subject is expected to participate in the study;

• Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or noncardiac cause of NVAF;

• Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments