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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
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

SAFE Trial 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.Check my eligibility
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.See study design
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.

SAFE Trial 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.

SAFE Trial 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

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

SAFE 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
368 Previous Clinical Trials
299,001 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
11,287 Patients Enrolled for Atrial Fibrillation
Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
677,912 Total Patients Enrolled
30 Trials studying Atrial Fibrillation
50,302 Patients Enrolled for Atrial Fibrillation
Emilie Belley-CôtéPrincipal InvestigatorPopulation Health Research Institute
1 Previous Clinical Trials

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for participants to join this research initiative?

"According to clinicaltrials.gov, this medical trial is now closed for enrollment as it was last updated on October 31st 2022. Initially posted on March 1st 2023, the study has since ceased recruiting patients; however, 1153 other trials remain open and actively seeking new participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Surgical Ablation of AF Efficacy Trial
Richard Whitlock 2023. "Surgical Ablation of AF Efficacy Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05434819.
All > Afib > Atrial Fibrillation
~1333 spots leftby Sep 2026
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