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Surgical Ablation of AF Efficacy Trial

RECRUITINGN/ASponsored by Population Health Research Institute
Actively Recruiting
PhaseN/A
SponsorPopulation Health Research Institute
Started2023-06-01
Est. completion2026-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05434819

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Atrial FibrillationHeart DiseaseHeart Failure

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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