Atrial Fibrillation Paroxysmal
Conditions
Keywords
pulsed field ablation, paroxysmal atrial fibrillation, left atrium posterior wall isolation, pulmonary vein isolation
Brief summary
The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).
Detailed description
This is an investigator-initiated, prospective, randomized, multi-center, Investigational Device Exemption (IDE) study. Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI) using pulsed field ablation (PFA) with the FARAWAVE PFA catheter. Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy. The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.
Interventions
DEVICEFarapulse PFA, Pulmonary Vein Isolation alone
Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
DEVICEFarapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
Sponsors
Jorge Romero
Boston Scientific Corporation
Databean
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age 21-90 years. 4. Symptomatic PAF whether failed AAD or not. 5. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment. 6. Patients undergoing first time ablation for AF. 7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.
Exclusion criteria
1. Persistent atrial fibrillation (PeAF) (\> 7 days in duration). 2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause. 3. Previous surgical or catheter ablation of AF. 4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve. 5. Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2. 6. Contraindications to oral or systemic anticoagulation. 7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months. 8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months. 9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days). 10. Pregnancy. 11. History of PV stenosis. 12. History of severe pulmonary hypertension. 13. History of diaphragmatic paresis or hemi-paresis. 14. History of heart transplantation. 15. History of blood clotting or bleeding abnormalities. 16. Life expectancy of less than 12 months. 17. Presence of intracardiac thrombus. 18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries. 19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA. 20. Pacing dependent patients. 21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma). 22. Active systemic infection. 23. Participation in any other AF-related randomized clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period. | 12 months | will be assessed by: * Occurrence of all atrial arrhythmias after the 3-month blanking period. * Any cardioversion for atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) after the 3-month blanking period. * Use of any type I or type III antiarrhythmic medication for the treatment of AF, AFL, or AT after the 3-month blanking period, or the use of amiodarone at any time. * Re-ablation of AF, AFL, or AT. |
| The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure. | 12 Months | All number of acute procedure-related complications will be reported and assessed including: atrio-esophageal fistula, cardiac perforation, pulmonary vein (PV) stenosis, acute kidney injury, phrenic nerve paralysis, thromboembolic events, stroke, or transient ischemic attacks (TIA), and other major adverse events within the 12 months following the ablation procedure: pericarditis cardiac tamponade pericardial effusion, coronary artery spasm, Vascular access complication/major bleeding, local hematoma, ecchymosis left atrium or vascular laceration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial arrhythmias medication | 12 Months | Time and dose of anti arrhythmic medications use will be compared between the two groups. |
| Procedural time | 12 Months | procedural time will be compared among groups. |
| Procedure-related Recurrencies | 12 Months | Rate of PV and PW reconnection in patients undergoing repeat ablation procedures for recurrence of AF. |
| Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT). | 12 Months | It reports scores from 0 to 100. A score of 0 corresponds to complete disability, while a score of 100 describes the highest level of QoL |
| Use of amiodarone | 12 months | Number of patients using amiodarone, and duration of using it will be compared among groups. |
| Complications. | 12 Months. | Incidence of acute procedure-related complications and long-term procedure-related complication. |
| fluoroscopy time. | during 1-2 hours procedure. | fluoroscopy time will be asses between the two groups. |
| Pulsed field ablation (PFA) applications during procedure. | During 1-2 hours procedure. | The PFA count will be compared by the two groups. |
| first-pass pulmonary vein isolation (PVI). | During 1-2 hours procedure. | the rates of first pass PVI will be compared between the two groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJorge E Romero, MD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORWilliam H Sauer, MD
Massachusetts General Hospital
Outcome results
None listed