Two Pulse Field Ablation Systems for Atrial Fibrillation
Official title: Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial
Run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · NCT07883629 · Data updated 2026-11-12
This trial tests whether two different pulse field ablation systems perform similarly in persistent symptomatic AF patients, with a heart monitor implanted to track rhythm for up to 36 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | July 10, 2026 |
| Main results expected | August 30, 2028 |
| Study ends | May 30, 2031 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07883629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–89 with symptomatic persistent AF undergoing de novo PFA ablation, able to consent and comply with follow-up.
✕Probably not a fit
Patients with specific exclusion criteria (e.g., significant LV dysfunction, large atrial size, severe renal impairment, or contraindication to anticoagulation) may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, pilot, randomized trial compares two standard PFA catheter systems (System A and System B) in adults with persistent symptomatic AF undergoing de novo ablation. Participants are randomly assigned to receive either System A or System B ablation, and all will have an implantable cardiac monitor placed during the procedure to continuously track heart rhythm. Follow-up visits include ECGs, ICM interrogations, adverse event updates, and quality-of-life assessments through Month 36. The study aims to determine differences in AF/AT/AT recurrence between the two ablation systems using a parallel-group, single-blind design with 60 participants per arm. Primary safety and efficacy outcomes are assessed in a real-world clinical setting.
Why it matters
Potential benefit: If one system proves superior or non-inferior, patients may experience fewer AF recurrences and potentially better long-term rhythm control.
How similar studies have gone: Previous PFA studies show promise for rhythm control, but comparative data between different PFA systems in this exact setting are limited, making this comparative trial relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Amit Thosani, MD — Allegheny Health Network
- Study coordinator: Amit Thosani, MD
- Email: amit.thosani@ahn.org
- Phone: 412-359-3457
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.