CompletedPhase 4

A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

United States, France, Switzerland112 participantsStarted 2003-08-01

Plain-language summary

The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older * Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month * Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III * Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor Exclusion Criteria: * Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants * History of any previous ablation for atrial fibrillation * Intracardiac thrombus * Atrial fibrillation due to reversible cause * Pregnancy * Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence of Atrial Fibrillation

Timeframe: One year

Trial details

NCT IDNCT00540787

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-06-01

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.