Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05434819

Surgical Ablation of AF Efficacy Trial

Led by Population Health Research Institute · Updated on 2025-03-04

2000

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

Sponsors

P

Population Health Research Institute

Lead Sponsor

H

Hamilton Health Sciences Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.

CONDITIONS

Official Title

Surgical Ablation of AF Efficacy Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years
  • Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof
  • Documented history of paroxysmal or persistent atrial fibrillation
  • Provide informed consent
Not Eligible

You will not qualify if you...

  • Dominant atrial arrhythmia is atrial flutter
  • Documented left atrial diameter 63 6 cm
  • Previous cardiac surgery requiring opening of the pericardium
  • Patients undergoing heart transplant
  • Patients undergoing complex congenital heart surgery
  • Sole indication for surgery is ventricular assist device insertion
  • Mitral valve repair or replacement
  • Tricuspid valve repair or replacement
  • Patient resides in a long-term care facility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

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Research Team

R

Richard Whitlock

CONTACT

S

SAFE Coordinators

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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