A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
NCT ID: NCT04524364
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
272 participants
INTERVENTIONAL
2020-08-23
2023-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with Paroxysmal Atrial Fibrillation (PAF)
Participants with PAF and who are candidates for catheter ablation will be enrolled.
Pulsed Field Ablation (PFA) Therapy
Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).
Interventions
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Pulsed Field Ablation (PFA) Therapy
Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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))
18 Years
75 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Locations
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Medical University Graz
Graz, , Austria
Ordensklinikum Linz Elisabethinen
Linz, , Austria
OLV Aalst
Aalst, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
Genk, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
London Health Sciences Centre
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, , Canada
University Hospital Center Split
Split, , Croatia
Nemocnice na Homolce
Prague, , Czechia
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, , France
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, , Italy
Vilnius University Hospital
Vilnius, , Lithuania
Countries
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References
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De Potter T, Grimaldi M, Duytschaever M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE. Circ Arrhythm Electrophysiol. 2024 May;17(5):e012667. doi: 10.1161/CIRCEP.123.012667. Epub 2024 Apr 24.
Duytschaever M, De Potter T, Grimaldi M, Anic A, Vijgen J, Neuzil P, Van Herendael H, Verma A, Skanes A, Scherr D, Purerfellner H, Rackauskas G, Jais P, Reddy VY; inspIRE Trial Investigators. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. doi: 10.1161/CIRCEP.122.011780. Epub 2023 Feb 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BWI_2019_08
Identifier Type: OTHER
Identifier Source: secondary_id
BWI_2019_08
Identifier Type: -
Identifier Source: org_study_id
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