To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
A prospective, multi-center, non-randomized, unblinded pre-market study designed to provide clinical data to support regulatory approval of the Argá Medtech CSE Ablation System for the ablation of atrial fibrillation and adjunctive use for additional atrial ablation. Patients with a history of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PersAF) will, at a minimum, undergo ablative intervention of the pulmonary veins.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Grandview
Birmingham, Alabama, United States
Safety: Number of Participants With at Least One Primary Safety Event.
Primary safety events are: Within 7 days of the index procedure: * Complete heart block * Coronary spasm * Myocardial infarction * Peripheral or organ thromboembolism * Stroke * Transient ischemic attack * Unresolved phrenic nerve palsy * Vascular access complications * Pericarditis Within 30 days of the index procedure: * Acute renal failure * Cardiac tamponade / perforation * Cardiovascular or pulmonary Pulsed Field Ablation (PFA)-related hospitalization * Death * Gastroparesis * Major bleeding Within180 days of the index procedure: * Pulmonary vein stenosis (≥70% diameter reduction) * Esophageal perforating complications
Time frame: Up to 180 days
Effectiveness: Number of Participants With Treatment Success.
Treatment success is defined as freedom from treatment failure. 1. Acute Procedural Success and 2. Chronic Success: * Documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) on a 12-lead electrocardiogram (ECG), event monitor, or Holter monitor after the 90-day Blanking Period * Re-ablation in the left atrium for AF, AFL, or AT * Any electrical cardioversion for AF, AFL, or AT * Any Class I or III antiarrhythmic (AAD) dose increase from the historic maximum ineffective dose prior to the Index Procedure or initiation of any new Class I or III AAD.
Time frame: Up to 12 months
Quality of Life - Change in EQ-5D-3L Score
Change in EQ-5D-3L score (12-month score - baseline score). The Euroqol EQ-5D-3L questionnaire (3L version) is a standardized instrument for measuring general health status. The Euroqol EQ-5D-3L questionnaire (which consists of a 5-question survey and a visual analog scale) has a composite score based on the 5-question survey that ranges from 0 (least healthy) to 1 (most healthy).
Time frame: Baseline to 12 months post-ablation
Quality of Life - Change in The AF Effect on Quality-of-Life questionnaire (AFEQT) Score
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Banner University Med Ctr
Phoenix, Arizona, United States
NOT_YET_RECRUITINGArrhythmia Research Group
Jonesboro, Arkansas, United States
RECRUITINGUCSD
San Diego, California, United States
NOT_YET_RECRUITINGAscension / St. Vincent's Jacksonville
Jacksonville, Florida, United States
RECRUITINGEmory
Atlanta, Georgia, United States
RECRUITINGNorthside Hospital
Atlanta, Georgia, United States
RECRUITINGPrairie Education & Research Cooperative
Springfield, Illinois, United States
RECRUITINGKansas City Heart Rhythm Institute (KCHRI)
Overland Park, Kansas, United States
RECRUITINGBaptist Health Lexington
Lexington, Kentucky, United States
RECRUITING...and 14 more locations
Change in AFEQT score (12-month score - baseline score). The AFEQT questionnaire is an atrial fibrillation (AF) specific health-related quality of life questionnaire to assess the impact of AF on a subject's life. The overall score ranges from 0 - 100, with 0 corresponding to complete disability and 100 corresponding to no disability.
Time frame: Baseline to 12 months post-ablation