Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT00911508) enrolled 2,204 people with atrial fibrillation (an irregular heartbeat condition). Participants were split into two groups: 1,108 people received a procedure called left atrial ablation (where heart tissue is targeted to try to correct the irregular rhythm), and 1,096 people received standard medication-based treatment to either control their heart rate or rhythm. The trial was measuring serious health events over time, including death, disabling stroke, serious bleeding, and cardiac arrest. The reported data shows that for the main outcome — the number of people who experienced at least one of those serious events — 89 participants in the ablation group and 101 participants in the medication group met that combined measure. For individual secondary outcomes, the reported data shows: all-cause death occurred in 58 people in the ablation group and 67 in the medication group; death or a hospital stay for a heart-related reason was recorded in 573 versus 637 people respectively; death, disabling stroke, or hospitalisation for heart failure or a heart attack was recorded in 170 versus 189 people; death specifically from a heart-related cause occurred in 22 versus 23 people; and the combination of heart-related death or disabling stroke was recorded in 24 versus 27 people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Atrial Fibrillation Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have had at least 2 episodes of atrial fibrillation (an irregular heartbeat) in the past 6 months, each lasting at least 1 hour, with at least one confirmed by a heart tracing (ECG); OR one longer episode lasting 7 or more days confirmed by ECG; OR one continuous episode lasting more than 1 year confirmed by ECG.
- Your doctor has decided you need active treatment for your atrial fibrillation within the past 3 months — not just monitoring.
- You are suitable for a catheter-based heart procedure (ablation) and have tried, or could try, at least 2 medications to control your heart rhythm and/or at least 2 medications to control your heart rate.
- You are 65 years of age or older, OR you are under 65 but have at least one stroke risk factor such as: high blood pressure, diabetes, heart failure, a previous stroke or mini-stroke, blood vessel disease (such as a previous heart attack), an enlarged left chamber of the heart, or a weakened heart pumping function.
- If you are under 65 and high blood pressure is your only risk factor, you must also have a second risk factor or an enlarged heart muscle to qualify (confirm with trial site).
- You are at least 18 years old.
- You are able to understand and sign a consent form agreeing to take part in the trial.
Who may not be able to join:
- You are under 65 and have atrial fibrillation with no stroke risk factors.
- Your doctor does not feel you need any treatment for your atrial fibrillation yet.
- You have already tried more than 2 anti-arrhythmic (heart rhythm) medications at full doses and they did not work or caused unacceptable side effects.
- You have previously taken the heart medication amiodarone at full dose for more than 8 weeks and it did not work.
- Your atrial fibrillation is caused by a reversible condition, such as a thyroid problem, recent heavy alcohol use, a recent major surgery, or an injury.
- You have had a heart attack, a heart procedure (such as a stent), or heart surgery (valve or bypass) in the past 3 months.
- You have a specific type of thickened heart muscle condition that blocks blood flow out of the heart (hypertrophic obstructive cardiomyopathy).
- You have very severe chest pain (Class IV angina) or very severe heart failure (Class IV), including if a heart transplant has been done or is planned.
- You have other dangerous heart rhythm problems (such as ventricular tachycardia or ventricular fibrillation) that require their own medication.
- You have an inherited heart rhythm condition or a condition that puts you at high risk of a dangerous reaction to certain heart rhythm medications (confirm with trial site).
- You have previously had a catheter procedure specifically to treat atrial fibrillation.
- You have previously had surgery to treat atrial fibrillation, such as a MAZE procedure.
- You have previously had a procedure to interrupt the electrical signal between the upper and lower chambers of your heart (AV nodal ablation).
- You need a catheter procedure for a different heart rhythm problem.
- You cannot safely take blood-thinning medication.
- You have kidney failure and need dialysis.
- You have a medical condition that means you are not expected to live more than 1 year.
- You are a woman who could become pregnant (unless you have been through menopause or have had a surgical procedure that prevents pregnancy).
- You are already taking part in another clinical trial that is studying survival outcomes.
- You are unable to give your own informed consent to participate.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.