Status:
COMPLETED
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atr...
Eligibility Criteria
Inclusion
- Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
- Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
- Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous left atrium (LA) ablation or surgery
- Participant known to require ablation outside the PV region (example. cavotricuspid isthmus \[CTI\] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
- Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
- Severe dilatation of the LA (LAD \>50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))
Key Trial Info
Start Date :
August 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2023
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04524364
Start Date
August 23 2020
End Date
May 9 2023
Last Update
May 25 2025
Active Locations (13)
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1
Medical University Graz
Graz, Austria, 8036
2
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
3
OLV Aalst
Aalst, Belgium, 9300
4
AZ Sint-Jan Brugge
Bruges, Belgium, 8000