NCT05552963Completed
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Multi-electrode Circular IRE Catheter and Multi-Channel IRE Generator in Paroxysmal AF
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 142 (actual)
- First submitted
- 21 Sept 2022
- Start date
- 7 Dec 2022
- Primary completion date
- 18 Dec 2024
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05552963
What you commit to
- Study type: Interventional
- Participants enrolled: 142
- From 7 Dec 2022 to the primary completion date, 18 Dec 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrium (LA) ablation or surgery
- 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)
Other illness
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
Related publications
- 12-Month Clinical Outcomes Using a Variable-Loop Circular Catheter for PFA in a Chinese Atrial Fibrillation Population.Pacing Clin Electrophysiol · 2026 · PMID 42205100
This page is information, not medical advice. Discuss any trial with your doctor.