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

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01729871

Run by

Janssen Scientific Affairs, LLC

People needed

253

Starts

2013-02-01

Expected to finish

2014-10-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Maywood, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Saint Louis Park, Minnesota, United States
• Study site — Ridgewood, New Jersey, United States
• Study site — Flushing, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Tacoma, Washington, United States
• Study site — Aalst, Belgium

Full record on ClinicalTrials.gov

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