Status:
UNKNOWN
The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Jiangxi Provincial People's Hopital
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)
Detailed Description
This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are ...
Eligibility Criteria
Inclusion
- Paroxysmal Atrial Fibrillation (PAF)
Exclusion
- A history of atrial fibrillation ablation;
- Left ventricular ejectfraction(LVEF)\<35%
- Left Atrium(LA)（echocardiography）\>55mm
- Thrombus in the left atrial or heart before surgery
- New York Heart Association(NYHA) grade Ⅲ-Ⅳ
- second or third degree atrioventricular block
- Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale)
- Prosthetic valves
- Pacemakers or defibrillators (ICD)
- Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
- Symptomatic carotid stenosis
- Untreated or uncontrolled hyperthyroidism or hypothyroidism
- Systemic active infection
- Renal failure with obvious bleeding tendency or undergoing hemodialysis
- Myocardial infarction or any cardiac intervention/open surgery within 3 months
- Stroke or transient ischemic attack within 6 months
- Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation
- Pregnant or lactating women or those who planned to have a family during the study period
- Have participated in clinical trials of other drugs or medical devices within 3 months
- Unsuitable to participate in this clinical trial by the investigator
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05400928
Start Date
July 5 2021
End Date
December 31 2023
Last Update
June 2 2022
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030