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โ† Trials
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Comparison of Two Pulse Field Ablation Systems for AF Ablation

RecruitingNAAges 18 Years - 89 YearsAllAllegheny Singer Research Institute (also known aโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Pulse Field Ablation
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Where

1 site
Allegheny General Hospital
Pittsburgh, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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