An interventional study of Pulse Field Ablation in AF - Atrial Fibrillation, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Treatment
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.
The purpose of this study is to compare the efficacy of de novo catheter ablation for persistent AF with System A versus System B pulse field ablation systems to reduce the incidence of AF/AFl/AT recurrence.
Single center, pilot, parallel group, two-arm, single-blind, randomized clinical trial 120 patients (60 per arm)
Subjects will be randomly assigned to one of two pulse field ablation (PFA) treatment procedures (A and B) that are commonly performed in patients with persistent, symptomatic atrial fibrillation The two procedures are performed the same way but using different cardiac catheters. Both of these procedures are performed routinely in the clinical setting.
A. Ablation of your heart using a System A PFA system through a cardiac catheter B. Ablation of your heart using an System B PFA system inserted through a cardiac catheter To monitor the heart after the ablation, an implantable cardiac monitor (ICM) will be implanted under the skin of the subject's chest during the ablation procedure. The risks associated with the ICM device are movement under the skin, erosion of the skin over the device or tissue trauma, infection at the implantation site, and an allergic reaction to or rejection of the device.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 120 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 47 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
Any of the following within the 3-months prior to enrollment:
Pulse Field System A through a standard ablation catheter
Procedure: Pulse Field Ablation
Pulse Field System A through a standard ablation catheter
Procedure: Pulse Field Ablation
Pulse Field Ablation
Number of participants free of AF, AFl, or AT recurrence
AF/AFl/AT Recurrence
Time frame: 12 months
Number of participants free of AF, AFl, or AT recurrence
AF/AFl/AT Recurrence
Time frame: 36 months
Number of participants free of repeat ablation
Repeat AF ablation within 12 months of randomization
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)