Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
Megadott ok: Insufficient enrollment related to ILR coverage barriers and the resulting inability to meet timelines with the available funding.
Key facts
- Where
- Birmingham, Boise, Boston, Burlington, Charleston, Doylestown, Houston, Jacksonville, Manhasset, Miami, Paramus, Portland, Royal Oak, San Antonio, Seattle és Washington D.C., Egyesült ÁllamokSee the 18 sites
Where in Egyesült Államok
- Grandview Medical CenterBirmingham, Egyesült ÁllamokNo longer taking part
- St. Luke's Boise Medical CenterBoise, Egyesült ÁllamokNo longer taking part
- Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
- Lahey Hospital and Medical CenterBurlington, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- Trident Medical CenterCharleston, Egyesült ÁllamokNo longer taking part
- Doylestown HospitalDoylestown, Egyesült ÁllamokNo longer taking part
- Orion MedicalHouston, Egyesült ÁllamokNo longer taking part
- St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent'sJacksonville, Egyesült ÁllamokNo longer taking part
- North Shore University Hospital - Northwell HealthManhasset, Egyesült ÁllamokNo longer taking part
- HCA Florida Mercy HospitalMiami, Egyesült ÁllamokNo longer taking part
- The Valley HospitalParamus, Egyesült ÁllamokNo longer taking part
- Maine Medical CenterPortland, Egyesült ÁllamokNo longer taking part
- Corewell Health William Beaumont HospitalRoyal Oak, Egyesült ÁllamokNo longer taking part
- Methodist Hospital San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
- University of Texas Health Science Center at San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
- University of Washington Medical CenterSeattle, Egyesült ÁllamokNo longer taking part
- MedStar Washington Hospital CenterWashington D.C., Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Jorge Romero
- Trial code
- NCT06364215
- Record updated
- 2026. május 15.
- Original description
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).Read full original descriptionShow less
Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation
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).
Inclusion: Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Age 21-90 years; Symptomatic PAF whether failed AAD or not; 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; Patients undergoing first time ablation for AF; Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.
Exclusion: Previous surgical or catheter ablation of AF; Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve; Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months; Previous myocardial infarction or percutaneous coronary intervention within the past 2 months; Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days); Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause; History of PV stenosis; History of severe pulmonary hypertension; History of diaphragmatic paresis or hemi-paresis; History of heart transplantation; History of blood clotting or bleeding abnormalities; Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries; Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma); Active systemic infection; Persistent atrial fibrillation (PeAF) (> 7 days in duration); Left atrium anteroposterior (LA AP) diameter >55 mm or indexed left atrium (LA) volume >48 ml/m2; Contraindications to oral or systemic anticoagulation; Pregnancy; Life expectancy of less than 12 months; Presence of intracardiac thrombus; Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA; Pacing dependent patients; Participation in any other AF-related randomized clinical trial.