Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
NCT06784466 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2026-04-08
Summary
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Conditions
- Atrial Fibrillation (AF)
- Persistant Atrial Fibrillation
- Paroxysmal AF
Interventions
- DEVICE
-
Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Sponsors & Collaborators
-
Arga Medtech SA
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-10
- Primary Completion
- 2027-06-30
- Completion
- 2027-08-31
- FDA Device
- Yes
Countries
- United States
- Belgium
- Croatia
- Czechia
- Lithuania
- Netherlands
Study Locations
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