Surgical ablation for treating atrial fibrillation during heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SAFE trial is an international multicenter randomized controlled trial investigating the efficacy of surgical ablation for atrial fibrillation (AF) in patients undergoing cardiac surgery. It aims to determine whether surgical ablation can improve cardiovascular outcomes by maintaining sinus rhythm in patients with paroxysmal or persistent AF. The trial will compare outcomes between patients receiving surgical ablation and those receiving standard care, with a focus on the potential benefits of this intervention in reducing the risk of stroke and heart failure. This landmark trial seeks to provide robust evidence on the impact of surgical AF ablation in the context of cardiac surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years;
* Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;
* Documented history of paroxysmal or persistent AF
* Provide informed consent

Exclusion Criteria:

* Dominant atrial arrhythmia is atrial flutter;
* Documented left atrial diameter ≥ 6 cm;
* Previous cardiac surgery requiring opening of the pericardium;
* Patients undergoing any of the following procedures:

  1. Heart transplant
  2. Complex congenital heart surgery
  3. Sole indication for surgery is ventricular assist device insertion
  4. Mitral valve repair or replacement
  5. Tricuspid valve repair or replacement
* Patient resides in a long-term care facility

Where it's running

• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Richard Whitlock — Population Health Research Institute
• Study coordinator: Richard Whitlock
• Email: Richard.Whitlock@phri.ca
• Phone: 905-521-2100

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.