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RECRUITING
NCT06784466
NA

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

Sponsor: Arga Medtech SA

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-09-10

Completion Date

2027-08

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DEVICE

Argá 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