A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
- Conditions
- Refractory Paroxysmal Atrial Fibrillation
- Interventions
- Device: Multi-Channel Irreversible Electroporation (IRE) GeneratorDevice: Multi-Channel Circular IRE Catheter
- Registration Number
- NCT05552963
- Lead Sponsor
- Biosense Webster, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Irreversible Electroporation (IRE) System Multi-Channel Irreversible Electroporation (IRE) Generator Participants 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. Irreversible Electroporation (IRE) System Multi-Channel Circular IRE Catheter Participants 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Long Term Effectiveness Without Antiarrhythmic Drug (AAD) Use 91-365 days post index procedure Long term effectiveness is defined as freedom more than or equal to (\>=) 30 seconds from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), and atrial flutter (AFL) of unknown origin based on electrocardiographic data during the effectiveness evaluation period.
- Secondary Outcome Measures
Name Time Method Number of Participants with AEs Up to 12 months An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with SAEs Up to 12 months An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with Acute Procedural Success Up to 12 months Acute Procedural Success defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter will be considered as acute procedural failure.
Number of Participants with Primary Adverse Events (PAEs) Within 7 days of ablation procedure An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with Rate of PV Up to 12 months Rate of PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted PVs and by subject.
Number of Participants with Serious Adverse Events (SAEs) Within 7 days, 8-30 Days and More Than 30 Days of Initial Ablation Procedure Within 7 days, 8-30 days and more than (>) 30 days of initial ablation procedure An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
Number of Participants with Acute Reconnection Up to 12 months Acute reconnection identified by adenosine/isoproterenol challenge. Among all clinically relevant targeted PVs and by subject.
Number of Participants with Rate of Repeated Ablation Up to 12 months Rate of repeated ablation within the 12 months follow-up period, including timing (blanking period or after blanking) and rate of PV reconnection.
Trial Locations
- Locations (6)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The first affiliated hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The first affiliated hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China