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Comparison of Two Pulse Field Ablation Systems for AF Ablation

Recruiting

Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial

Who can join

Ages 18 to 89 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Symptomatic AF
* Persistent AF
* De novo AF ablation
* Males and Females Age 18 to 89 years of age, inclusive
* Willing and capable to provide informed consent
* Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study

Exclusion Criteria:

* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
* Contraindication to, or unwillingness to use, systematic anticoagulation
* Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior)
* Left atrial volume index \>60 ml/m2
* LA anteroposterior dimension 5.5 cm
* Presence of intramural thrombus, tumor or other abnormality that precludes safe catheter introduction or manipulation
* BMI \>35 kg/m2
* Chronic renal insufficiency of \<15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant
* Clinically significant systemic infection or sepsis
* Any of the following within the 3-months prior to enrollment:

  * Myocardial infarction
  * Unstable angina
  * Percutaneous coronary intervention
  * Heart failure hospitalization
  * Stroke or TIA
  * Significant bleeding
  * Pericarditis/effusions
  * Left atrial thrombus
  * Coronary artery bypass grafting/atriotomy within 6 months prior
  * Contraindication for oral anticoagulation
  * Organ or hematologic transplant, or currently being evaluated for an organ transplant Women who are pregnant or breastfeeding

About the study

This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems. The patient will have an ICM placed to continuously monitor their heart rhythm. Follow up visits will occur until Month 36, and will include 12-lead ECG, ICM interrogation, AE updates, and QOL surveys.

What is being tested

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Participants: 120 · Started: Jul 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07883629

Locations in the U.S.

PennsylvaniaAllegheny General Hospital, Pittsburgh

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.