RecruitingNot ApplicableNCT06784466

Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation

Sponsor

Arga Medtech SA

Enrollment

360 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Persistant Atrial Fibrillation Paroxysmal AF

Summary

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of heart rhythm procedure called Coherent Sine Burst Electroporation (CSE) ablation for people with atrial fibrillation (AFib), an irregular heartbeat. Unlike traditional heat-based ablation, this method uses precise electrical pulses to correct the irregular rhythm. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with AFib that keeps coming back despite medication - You have had at least 2 episodes of AFib in the past 6 months - At least one AFib episode has been documented by a heart monitor in the past year **You may NOT be eligible if...** - You have never tried medications to control your AFib - You have certain heart structural problems or blood clots - You have had a previous AFib ablation procedure - You have other serious health conditions that make this procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEArgá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Locations(27)

Grandview

Birmingham, Alabama, United States

Banner University Med Ctr

Phoenix, Arizona, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

UCSD

San Diego, California, United States

Ascension / St. Vincent's Jacksonville

Jacksonville, Florida, United States

Advent Health

Orlando, Florida, United States

Emory

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Prairie Education & Research Cooperative

Springfield, Illinois, United States

Kansas City Heart Rhythm Institute (KCHRI)

Overland Park, Kansas, United States

Baptist Health Lexington

Lexington, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

TriHealth Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio Health Research and Innovation Institute

Columbus, Ohio, United States

Trident Medical Center

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Methodist

San Antonio, Texas, United States

AZorg Aalst

Aalst, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

KBC Split

Split, Croatia

KBC Zagreb

Zagreb, Croatia

Neuron Medical s.r.o.

Brno, Czech Republic, Czechia

Institut klinické a experimentální medicíny (IKEM)

Prague, Czech Republic, Czechia

Motol and Homolka University Hospital

Prague, Czechia

Vilnius University Hospital Santariskiu Klinikos

Vilnius, Lithuania

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06784466

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