Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation
NCT05572047 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-12-05
Summary
To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.
Conditions
Interventions
- DEVICE
-
Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF
Sponsors & Collaborators
-
Arga Medtech SA
lead INDUSTRY
Principal Investigators
-
Ante Anic, MD · University Hospital of Split
-
Giorgi Papiashvili · Israeli-Georgian Medical Research Clinic Helsicore
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-11
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- Croatia
- Georgia
Study Locations
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