PersAFOne III: Feasibility Study of the FARAPULSE Pulsed Field Ablation System Plus - PersAF in the Treatment of Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial Fibrillation
- Registration Number
- NCT05272852
- Lead Sponsor
- Farapulse, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Study subjects are required to meet all the following inclusion criteria to participate<br>in this study:<br><br> 1. Patients with documented drug-resistant symptomatic persistent AF meeting all three<br> of the following criteria:<br><br> 1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic<br> agent.<br><br> 2. ECG-documented first episode of persistent AF, lasting longer than 7 days but<br> not longer than 365 days<br><br> 3. Holter within 90 days prior to the Enrollment Date demonstrating 24 hours of<br> continuous AF<br><br> 2. Patients who are = 18 and = 75 years of age on the day of enrollment.<br><br> 3. Patient participation requirements:<br><br> 1. Lives locally<br><br> 2. Is willing and capable of providing Informed Consent to undergo study<br> procedures<br><br> 3. Is willing to participate in all examinations and follow-up visits and tests<br> associated with this clinical study<br><br> - Exclusion Criteria:<br><br>Subjects will be excluded from participating in this study if they meet any one of the<br>following exclusion criteria:<br><br> 1. AF that is:<br><br> 1. Paroxysmal (longest AF episode < 7days)<br><br> 2. Longstanding (has persisted > 12 months or that does not respond to<br> cardioversion if < 12 months)<br><br> 3. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other<br> reversible / non-cardiac causes<br><br> 2. Left atrial anteroposterior diameter = 5.5 cm as documented by transthoracic<br> echocardiography (TTE) or computed tomography (CT)<br><br> 3. Any of the following cardiac procedures, implants or conditions:<br><br> 1. Clinically significant arrhythmias other than AF, AFL or AT<br><br> 2. Hemodynamically significant valvular disease<br><br> 3. Prosthetic heart valve<br><br> 4. NYHA Class III or IV CHF<br><br> 5. Previous endocardial or epicardial ablation or surgery for AF<br><br> 6. Atrial or ventricular septal defect closure<br><br> 7. Atrial myxoma<br><br> 8. Left atrial appendage device or occlusion<br><br> 9. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization<br> therapy devices<br><br> 10. Significant or symptomatic hypotension<br><br> 11. Bradycardia or chronotropic incompetence<br><br> 12. History of pericarditis<br><br> 13. History of rheumatic fever<br><br> 14. History of congenital heart disease with any residual anatomic or conduction<br> abnormality<br><br> 4. Any of the following within 3 months prior toenrollment:<br><br> 1. Myocardial infarction<br><br> 2. Unstable angina<br><br> 3. Percutaneous coronary intervention<br><br> 4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)<br><br> 5. Heart failure hospitalization<br><br> 6. Stroke or TIA<br><br> 7. Clinically significant bleeding<br><br> 8. Pericarditis or pericardial effusion<br><br> 9. Left atrial thrombus<br><br> 5. History of blood clotting or bleeding abnormalities.<br><br> 6. Contraindication to, or unwillingness to use, systemic anticoagulation<br><br> 7. Contraindications to CT or MRI<br><br> 8. Sensitivity to contrast media not controlled by premedication<br><br> 9. Women of childbearing potential who are pregnant, lactating or not using birth<br> control<br><br> 10. Medical conditions that would prevent participation in the study, interfere with<br> assessment or therapy, significantly raise the risk of study participation, or<br> confound data or its interpretation, including but not limited to<br><br> 1. Body mass index (BMI) > 40<br><br> 2. Solid organ or hematologic transplant, or currently being evaluated for an<br> organ transplant<br><br> 3. Severe lung disease, pulmonary hypertension, or any lung disease involving<br> abnormal blood gases or significant dyspnea<br><br> 4. Renal insufficiency with an estimated creatinine clearance <30 mL/min/1.73 m2,<br> or any history of renal dialysis or renal transplant<br><br> 5. Active malignancy or history of treated cancer within 24 months of enrollment<br><br> 6. Clinically significant gastrointestinal problems involving the esophagus,<br> stomach and/or untreated acid reflux<br><br> 7. Clinically significant infection<br><br> 8. Predicted life expectancy less than one year<br><br> 11. Clinically significant psychological condition that in the investigator's opinion<br> would prohibit the subject's ability to meet the protocol requirements<br><br> 12. Current or anticipated enrollment in any other clinical study<br><br> 13. Employment by FARAPULSE or the same hospital department or office of any<br> investigator, or a family member of any of the preceding groups.<br><br> 14. Use of amiodarone after day of index ablation procedure. Patients will cease use of<br> amiodarone on or before the date of the index ablation procedure.<br><br>
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite Safety Endpoint (CSE) defined as the incidence of the following early-onset and late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the CEDMC
- Secondary Outcome Measures
Name Time Method The Primary Safety Endpoint assessed at 7 days;The proportion of subjects with a device- or procedure-related SAE;The proportion of subjects with stroke or TIA;The proportion of subjects requiring cardioversions;The proportion of subjects requiring an arrhythmia-related (AF, AFL or AT) hospitalization