Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatment approaches for patients with paroxysmal atrial fibrillation (PAF), a condition where the heart can beat irregularly and often feels like it’s racing. The study aims to compare the effectiveness and safety of a standard procedure called pulmonary vein isolation (PVI) against a new method that includes additional isolation of the back wall of the left atrium using a technique called pulsed-field ablation (PFA). By doing this, researchers hope to find out if the new method provides better results for managing PAF.

To participate in this trial, individuals should be between 21 and 90 years old and have experienced at least one episode of PAF that lasted less than a week in the past year. Participants must also be willing to follow all study procedures and agree to have a heart monitoring device implanted. However, those with certain medical conditions or previous heart surgeries may not be eligible. If you decide to join, you can expect to undergo these heart procedures, and the study team will closely monitor your progress to ensure your safety and the effectiveness of the treatment.

Gender

ALL

Eligibility criteria

• 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.