Comparing two pulse field ablation systems for treating atrial fibrillation
Compares two heart ablation systems in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Comparison of Two Pulse Field Ablation Systems for AF Ablation
Key facts
- Where
- Pittsburgh, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 89 years old?
Source: NCT07883629, who can take part
Where in United States
- Allegheny General HospitalPittsburgh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Trial code
- NCT07883629
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial
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.
Inclusion: 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: 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; AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes; 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; Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior); Contraindication to, or unwillingness to use, systematic anticoagulation; 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.