A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
CompletedNAResults postedLast updated 6 January 2026
What this trial tests
NA trial testing Multi-Channel Irreversible Electroporation (IRE) Generator in Refractory Paroxysmal Atrial Fibrillation in 142 participants. Completed in 18 December 2024.
Adults 18 to 80, any sex, with Refractory Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Long-term EffectivenessPrimary· From Day 91 up to Day 365 post-procedure on Day 0
Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardiov
Group
Value
95% CI
Irreversible Electroporation (IRE) System
74.6
66.86 – 82.32
Percentage of Participants Experiencing Primary Adverse Event (PAE)Secondary· Within 7 days post-procedure on Day 0
Percentage of participants experiencing PAE were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. Primary AEs within seven days of the ablation procedure which used investigational devices per protocol, including the initial and repeat procedures were reported. PAEs included cardiac tamponade, perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischaemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, pulmonary vein stenosis, pulmonary oedema (respirat
Group
Value
95% CI
Irreversible Electroporation (IRE) System
2.1
Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation ProcedureSecondary· From day of procedure (Day 0) up to 12 months
Percentage of participants with SAEs within 7 days (early-onset), 8-30 days (peri-procedural) and \>30 days (late onset) of initial ablation procedure were reported. A SAE was any adverse event (AE) that resulted in a death or a serious deterioration in the health of the participant during the clinical trial, including a life-threatening illness or injury, a permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a body function; o
Within 7 days (early-onset) of index ablation procedure
Group
Value
95% CI
Irreversible Electroporation (IRE) System
2.8
Within 8-30 days (peri-procedural)
Group
Value
95% CI
Irreversible Electroporation (IRE) System
0.7
>30 days (late onset)
Group
Value
95% CI
Irreversible Electroporation (IRE) System
6.3
Percentage of Participants With Acute Procedural SuccessSecondary· On the day of procedure (Day 0)
Percentage of participants with acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter was considered as acute procedural failure.
Group
Value
95% CI
Irreversible Electroporation (IRE) System
100
Percentage of Participants With Acute ReconnectionSecondary· On the day of procedure (Day 0)
Percentage of participants with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.
Group
Value
95% CI
Irreversible Electroporation (IRE) System
10.6
Percentage of Pulmonary Veins (PVs) With Acute ReconnectionSecondary· On the day of procedure (Day 0)
Percentage of PVs with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.
Group
Value
95% CI
Irreversible Electroporation (IRE) System
4.7
Percentage of Participants With Pulmonary Vein (PV) AblationSecondary· On day of procedure (Day 0)
Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported.
Group
Value
95% CI
Irreversible Electroporation (IRE) System
0
8.52 – 75.51
Percentage of Participants With Repeated AblationSecondary· From the day of procedure (Day 0) up to 12 months
Percentage of participants with repeated ablation within the 12 months follow up period, including timing (blanking period or after blanking) were reported. Repeat procedures for AF/AT/AFL of unknown origin plus recurrences during the blanking period (90 days post index procedure) were conducted with the investigational device for ablating PV reconnections. Repeat procedures performed after the blanking period were managed per investigator discretion using a commercially available ablation catheter and generator.
Group
Value
95% CI
Irreversible Electroporation (IRE) System
6.5
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of informed consent signing through 12 months post-procedure (on Day 0).
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Irreversible Electroporation (IRE) System
Serious: 16/142 (11%)
Deaths: 0/142
Serious adverse events (17 terms)
Reaction
System
Irreversible Electroporati…
Upper respiratory tract infection
Infections and infestations
—
Anaemia
Blood and lymphatic system disorders
—
Arteriosclerosis coronary artery
Cardiac disorders
—
Acute myocardial infarction
Cardiac disorders
—
Generalised anxiety disorder
Psychiatric disorders
—
Obsessive-compulsive disorder
Psychiatric disorders
—
Arteriovenous fistula
Vascular disorders
—
Dermatitis atopic
Skin and subcutaneous tissue disorders
—
Puncture site haematoma
General disorders
—
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
—
Vitreous haemorrhage
Eye disorders
—
Cataract nuclear
Eye disorders
—
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Schwannoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07527299 — A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior
· NA
· not yet recruiting
NCT07523750 — A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants Wit
· NA
· not yet recruiting
NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
· NA
· recruiting
NCT07428564 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
· NA
· not yet recruiting
NCT07227532 — A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Cathe
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Biosense Webster, Inc.
Last refreshed: 6 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05552963.