Surgical Ablation for Atrial Fibrillation (SAFE Trial)

N/A

Recruiting

Led By Emilie Belley-Côté

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof

Must not have

Dominant atrial arrhythmia is atrial flutter

Previous cardiac surgery requiring opening of the pericardium

Timeline

Screening 3 weeks

Treatment Varies

Follow Up beyond 6 weeks until common termination point for trial (median follow-up of 4 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to do a surgery to stop atrial fibrillation in people who are already undergoing cardiac surgery.

Who is the study for?

This trial is for adults over 18 with a history of paroxysmal or persistent atrial fibrillation who are already scheduled for certain heart surgeries like bypass grafting or aortic valve replacement. It's not open to those in long-term care, with very large left atria, primary atrial flutter, previous similar heart surgery, or needing complex procedures like transplants.

What is being tested?

The SAFE trial is testing the effectiveness of adding surgical ablation—a procedure that creates scars in the heart to prevent abnormal electrical signals—for treating atrial fibrillation during planned cardiac surgeries. This international study randomly assigns participants to receive this additional treatment.

What are the potential side effects?

While specific side effects aren't listed here, surgical ablation can generally include risks such as bleeding, infection at the incision site, and potential damage to surrounding heart structures which could lead to other complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for heart surgery, such as bypass or valve replacement.

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I have a history of irregular heartbeats.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My main heart rhythm problem is atrial flutter.

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I have had heart surgery that involved opening the protective covering of the heart.

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I am undergoing heart surgery, such as a transplant, valve repair, or getting a ventricular assist device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ beyond 6 weeks until common termination point for trial (median follow-up of 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~beyond 6 weeks until common termination point for trial (median follow-up of 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and beyond 6 weeks until common termination point for trial (median follow-up of 4 years) for reporting.