NCT07883629Recruiting
Comparison of Two Pulse Field Ablation Systems for AF Ablation
Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 10 Jul 2026
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Diseases
- Atrial fibrillation
- NCT number
- NCT07883629
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 10 Jul 2026 to the primary completion date, 30 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.