Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrilation:InsightPFA Trial
Status: Completed
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age between 18 and 75 years, of either sex.
• Patients with ECG-confirmed or clinically definite diagnosis of symptomatic paroxysmal atrial fibrillation (PAF).
• Scheduled to undergo catheter ablation for atrial fibrillation
• Willing to participate in this clinical trial, voluntarily sign the informed consent form, and commit to completing required examinations and follow-ups per protocol..
Locations
Other Locations
China
Beijing Anzhen Hospital
Beijing
The First Affiliated Hospital of Dalian Medical University
Dalian
Guangdong Provincial People's Hospital
Guangzhou
Nanfang Hospital, Southern Medical University
Guangzhou
Sir Run Run Shaw Hospital
Hanzhou
Yan'an Affiliated Hospital of Kunming Medical University
Kunming
The Affiliated People's Hospital of Ningbo University
Ningbo
Shanghai Zhongshan Hospital
Shanghai
Weifang People's Hospital
Weifang
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen
Time Frame
Start Date: 2023-09-04
Completion Date: 2025-07-03
Participants
Target number of participants: 292
Treatments
Experimental: Test group
Test group will utilize the cardiac PFA system (including a pulsed field generator, an expandable PFA catheter, and a steerable sheath) from Insight Medtech.
Active_comparator: Control group
The control group will utilize an RFA system (including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter) from Biosense Webster.
Related Therapeutic Areas
Sponsors
Collaborators: Beijing Anzhen Hospital, Weifang People's Hospital, Nanfang Hospital, Southern Medical University, The Affiliated People's Hospital of Ningbo University, The First Affiliated Hospital of Dalian Medical University, Insight Lifetech Co., Ltd., Guangdong Provincial People's Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Xiamen Cardiovascular Hospital, Xiamen University, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital
Leads: Insight Medtech Co., Ltd.