Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorArga Medtech SA
About this trial
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
Willing and able to give informed consent.
Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
Disqualifiers
In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial [LA] thrombus), trans-esophageal echocardiogram (TEE) or computed tomography (CT) scan, or anticoagulation.
Any duration of continuous AF lasting longer than 12 months.
History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
Trial design
Design model
Single group
Treatments tested in this trial
Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
DeviceAblation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Paroxysmal AFExperimental treatment 1 intervention
Group B: Persistent AFExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 monthsSecondary outcomes
1
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-ablation2
Quality of Life - Change in The AF Effect on Quality-of-Life questionnaire (AFEQT) Score
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-ablationSponsors and contacts
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Source ClinicalTrials.gov