Clinical trial NCT05552963: A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Number of Participants with Long Term Effectiveness Without Antiarrhythmic Drug (AAD) Use
timeFrame: 91-365 days post index procedure
Secondary outcomes:
measure: Number of Participants with Acute Procedural Success
timeFrame: Up to 12 months
measure: Number of Participants with Acute Reconnection
timeFrame: Up to 12 months
measure: Number of Participants with Rate of PV
timeFrame: Up to 12 months
measure: Number of Participants with Rate of Repeated Ablation
timeFrame: Up to 12 months
measure: Number of Participants with Primary Adverse Events (PAEs)
timeFrame: Within 7 days of ablation procedure
measure: Number of Participants with Serious Adverse Events (SAEs) Within 7 days, 8-30 Days and More Than 30 Days of Initial Ablation Procedure
timeFrame: Within 7 days, 8-30 days and more than (>) 30 days of initial ablation procedure
measure: Number of Participants with AEs
timeFrame: Up to 12 months
measure: Number of Participants with SAEs
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
state: Henan
city: Dalian
country: China
facility: The first affiliated hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Jianzeng Dong
role: STUDY_CHAIR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shaowen Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Hailong Tao
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Hua Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Yumei Xue
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University General Hospital
name: Heng Cai
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Lianjun Gao
role: PRINCIPAL_INVESTIGATOR
References: