Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT06784466
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-01-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Sponsor:
Arga Medtech SA
Organization:
Study Overview
Official Title:
Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COHERENT-AF
Brief Summary:
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Detailed Description:
A prospective, multi-center, non-randomized, unblinded pre-market study designed to provide clinical data to support regulatory approval of the Argá Medtech CSE Ablation System for the ablation of atrial fibrillation and adjunctive use for additional atrial ablation. Patients with a history of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PersAF) will, at a minimum, undergo ablative intervention of the pulmonary veins.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: