VARIPULSE Catheter
DevicePulsed Field Ablation using the VARIPULSE catheter.
NCT Number: NCT07523750
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).
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Arrhythmia Research Group, Jonesboro, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pulsed Field Ablation using the VARIPULSE catheter.
Pulsed field ablation using the FARAWAVE catheter.
Time frame: Up to 7 days post-index procedure
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: Day 61 and onward
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter [AF, AT or AFL] of unknown origin) episodes based on electrocardiographic data and freedom from 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: Baseline, at 6 months and at 12 months post-index procedure
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.
Contact information is provided by the study sponsor or research team.
Biosense Webster, Inc.
Industry
Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
Acronym: PERSIGMA RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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