N/A
Completed N=142
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
Refractory Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov NCT05552963 ↗
Enrolled (actual)
142
Serious AEs
11.3%
Results posted
Jan 2026
Primary outcomePrimary: Percentage of Participants With Long-term Effectiveness — 74.6 Percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Long-term Effectiveness |
74.6 | — |
| SECONDARY Percentage of Participants Experiencing Primary Adverse Event (PAE) |
2.1 | — |
| SECONDARY Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure |
2.8; 0.7; 6.3 | — |
| SECONDARY Percentage of Participants With Acute Procedural Success |
100 | — |
| SECONDARY Percentage of Participants With Acute Reconnection |
10.6 | — |
| SECONDARY Percentage of Pulmonary Veins (PVs) With Acute Reconnection |
4.7 | — |
| SECONDARY Percentage of Participants With Pulmonary Vein (PV) Ablation |
— | — |
| SECONDARY Percentage of Participants With Repeated Ablation |
6.5 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation [AF]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip
- Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD
- Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
- Willing and capable of providing consent
Exclusion Criteria
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity)
- Previous left atrium (LA) ablation or surgery
- Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
- Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
- Severe dilatation of the LA (documented LAD >50 millimeters [mm] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)
Data sourced from ClinicalTrials.gov (NCT05552963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.