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Procedure

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of hospital readmissions for heart failure over duration of follow-up
Secondary study objectives
Antiarrhythmic drug use
Cardiovascular mortality
Freedom from recurrence of atrial tachyarrhythmia
+8 more
Other study objectives
All-cause mortality
Atrial Fibrillation
Number of Ischemic stroke and systemic arterial embolism
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical Atrial Fibrillation Ablation GroupExperimental Treatment1 Intervention
Surgeon will perform left atrial ablation during patient's cardiac surgery procedure.
Group II: No Surgical Atrial Fibrillation Ablation GroupActive Control1 Intervention
Surgeon will not perform left atrial ablation during the patient's cardiac surgery procedure.

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER
377 Previous Clinical Trials
337,929 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
12,157 Patients Enrolled for Atrial Fibrillation
Population Health Research InstituteLead Sponsor
164 Previous Clinical Trials
716,514 Total Patients Enrolled
33 Trials studying Atrial Fibrillation
53,124 Patients Enrolled for Atrial Fibrillation
Emilie Belley-CôtéPrincipal InvestigatorPopulation Health Research Institute
2 Previous Clinical Trials
1,400 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
1,400 Patients Enrolled for Atrial Fibrillation
Richard WhitlockPrincipal InvestigatorPopulation Health Research Institute
2 Previous Clinical Trials
1,400 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
1,400 Patients Enrolled for Atrial Fibrillation

Media Library

Surgical Atrial Fibrillation Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05434819 — N/A
Atrial Fibrillation Research Study Groups: Surgical Atrial Fibrillation Ablation Group, No Surgical Atrial Fibrillation Ablation Group
Atrial Fibrillation Clinical Trial 2023: Surgical Atrial Fibrillation Ablation Highlights & Side Effects. Trial Name: NCT05434819 — N/A
Surgical Atrial Fibrillation Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05434819 — N/A
~1077 spots leftby Sep 2026
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