CompletedNot Applicable

STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial

Canada, Italy, Norway107 participantsStarted 2006-08

Plain-language summary

Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (\>4 episodes within 6 months, two episodes \>6 hours within 1 year) or persistent (sustained episode \<6 months terminated by cardioversion or drug). Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation

Who can participate

Age range

18 Years – 75 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: * Patients age 18 or greater. * "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation * candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication. * At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial. * continuous anticoagulation with warfarin (INR 2-3) for \>4 weeks prior to the ablation. * Patients must be able and willing to provide written informed consent to participate in the clinical trial. Exclusion Criteria: * chronic atrial fibrillation. * Patients with AF felt to be secondary to an obvious reversible cause. * inadequate anticoagulation as defined in the inclusion criteria. * left atrial thrombus or spontaneous echo contrast on TEE prior to procedure. * contraindications to systemic anticoagulation with heparin or coumadin. * previously undergone atrial fibrillation ablation. * left atrial size \> 55 mm. * Patients who are or may potentially be pregnant

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

Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.

Timeframe: 3 months

Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.

Timeframe: 12 months

Trial details

NCT IDNCT00367757

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07

View on ClinicalTrials.gov More Atrial Fibrillation trials