Surgical Ablation of AF Efficacy Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
About this trial
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Dominant atrial arrhythmia is atrial flutter;
Documented left atrial diameter ≥ 6 cm;
Previous cardiac surgery requiring opening of the pericardium;
Heart transplant
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical Atrial Fibrillation Ablation
Procedure/SurgerySurgeon will preform surgical atrial fibrillation ablation using either cryoablation or bipolar radiofrequency clamps including 2 layers of atrium or vein, a minimum of 2 burns per clamping with at least 3 lines in the ablation group. Cavo-tricuspid isthmus and mitral lines will be allowed.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Surgical Atrial Fibrillation Ablation GroupExperimental treatment 1 intervention
Group B: No Surgical Atrial Fibrillation Ablation GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of hospital readmissions for heart failure over duration of follow-up
Total number of hospital readmissions for heart failure.
Time frame
Common termination point for trial (median follow-up of 4 years)Secondary outcomes
1
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
Time frame
Common termination point for trial (median follow-up of 4 years)2
Length of ICU stay
Length of ICU stay, including readmissions, from study intervention surgery to hospital discharge, including readmissions
Time frame
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)3
Length of hospital stay
Length of hospital stay
Time frame
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)4
Freedom from recurrence of atrial tachyarrhythmia
Freedom from recurrence of atrial tachyarrhythmia
Time frame
1 year post-operativelyOther outcomes
1
Number of Ischemic stroke and systemic arterial embolism
Safety outcome
Time frame
Up to 30 days post-operatively2
Number of patients requiring permanent pacemaker implantation
Safety outcome
Time frame
Up to 1 year post-operatively3
Volume of chest tube output
Safety outcome - chest tube output measured in mL.
Time frame
Up to 24 hours post-operatively4
Re-operation for bleeding
Safety outcome
Time frame
From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Population Health Research Institute
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
Source ClinicalTrials.gov