The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
566
Pulsed Field Ablation using the VARIPULSE catheter.
Pulsed field ablation using the FARAWAVE catheter.
Arrhythmia Research Group
Jonesboro, Arkansas, United States
RECRUITINGOC Medical Center
Fountain Valley, California, United States
RECRUITINGOccurrence of Early Onset Primary Adverse Events (PAEs)
PAEs that include early onset AEs such as esophageal perforating complications, phrenic nerve paralysis (PNP; permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), death (device or procedure related), stroke/ cerebrovascular accident (CVA), major vascular access, complication/bleeding, thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), pericarditis, pulmonary edema (respiratory insufficiency), heart block, and vagal nerve injury/ gastroparesis.
Time frame: Up to 7 days post-index procedure
Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Time to occurrence of documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes based on electrocardiographic data (12-Lead Electrocardiogram (ECG) or greater than equal to (\>=) 30 seconds on sponsor provided Cardiac Event Monitor (CEM) or Patch arrhythmia monitor) during the effectiveness evaluation period or acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.
Time frame: Day 61 and onward
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Time frame: Baseline and at 6 months post procedure
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Community Memorial Hospital
Ventura, California, United States
RECRUITINGNCH Healthcare
Naples, Florida, United States
RECRUITINGLenox Hill Hospital
New York, New York, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGWakeMed Hospital
Raleigh, North Carolina, United States
RECRUITINGTexas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
RECRUITINGBaylor Research Institute
Plano, Texas, United States
RECRUITINGIntermountain Medical Center
Murray, Utah, United States
RECRUITING