AzTrials
AzTrials

Refractory Paroxysmal Atrial FibrillationAFIRENCT05552963

A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)

A study testing Multi-Channel Irreversible Electroporation (IRE) Generator and Multi-Channel Circular IRE Catheter in people with Refractory Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Multi-Channel Irreversible Electroporation (IRE) Generator and Multi-Channel Circular IRE Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
6 sitesChina
Study dates
7 Dec 2022to 18 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The first affiliated hospital of Dalian Medical University

    Dalian, Liaoning

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • The first affiliated hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

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).

Being tested
Multi-Channel Irreversible Electroporation (IRE) Generator, Multi-Channel Circular IRE Catheter
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Channel Irreversible Electroporation (IRE) GeneratorDevice

    Also called D-1417-01-I

    The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy.

  • Multi-Channel Circular IRE CatheterDevice

    Also called D-1412-01-SI

    The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation.

Study groups in NCT05552963
Study groupRoleWhat they receive
Irreversible Electroporation (IRE) SystemExperimentalParticipants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation will be treated with the IRE system which includes multi-electrode circular IRE catheter and the multi-channel IRE generator.
Receives: Device: Multi-Channel Irreversible Electroporation (IRE) Generator; Device: Multi-Channel Circular IRE Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Long-term Effectiveness

    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) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study.

    Measured: From Day 91 up to Day 365 post-procedure on Day 0

Secondary outcomes (7)

  1. Percentage of Participants Experiencing Primary Adverse Event (PAE)

    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 (respiratory insufficiency), vagal nerve injury/gastroparesis, pericarditis, major vascular access complication/bleeding, and atrio-esophageal fistula .

    Measured: Within 7 days post-procedure on Day 0

  2. Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure

    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; or resulted in fetal distress, foetal death or congenital abnormality, congenital anomaly, etc.

    Measured: From day of procedure (Day 0) up to 12 months

  3. Percentage of Participants With Acute Procedural Success

    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.

    Measured: On the day of procedure (Day 0)

  4. Percentage of Participants With Acute Reconnection

    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.

    Measured: On the day of procedure (Day 0)

  5. Percentage of Pulmonary Veins (PVs) With Acute Reconnection

    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.

    Measured: On the day of procedure (Day 0)

  6. Percentage of Participants With Pulmonary Vein (PV) Ablation

    Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported.

    Measured: On day of procedure (Day 0)

  7. Percentage of Participants With Repeated Ablation

    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.

    Measured: From the day of procedure (Day 0) up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start7 Dec 2022
  3. Primary completion18 Dec 2024
  4. Study completion18 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552963
Sponsor's protocol ID
BWI202107
Other IDs
BWI202107
Acronym
AFIRE
Status last verified
Dec 2025
First submitted
21 Sep 2022
Last updated
6 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Publications

  • Tao H, Cai H, Fu H, Liu S, Chen S, Gao L, Yin X, Xue Y, Liao H, Zeng R, Cui K, Dong J. 12-Month Clinical Outcomes Using a Variable-Loop Circular Catheter for PFA in a Chinese Atrial Fibrillation Population. Pacing Clin Electrophysiol. 2026 May 28. doi: 10.1111/pace.70294. Online ahead of print.

    PubMed 42205100

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Channel Irreversible Electroporation (IRE) Generator and Multi-Channel Circular IRE Catheter in people with Refractory Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Long-term Effectiveness (time frame: From Day 91 up to Day 365 post-procedure on Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05552963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in