Status:
NOT_YET_RECRUITING
PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Conditions:
Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In radiofrequency (RF) ablation of persistent atrial fibrillation (PeAF), the additional linear ablation beyond pulmonary vein isolation (PVI) does not yield an reduce atrial arrhythmias recurrences.T...
Detailed Description
Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI on...
Eligibility Criteria
Inclusion
- Patients diagnosed with symptomatic PeAF at 18-75 years old who are eligible for the PFA procedure, and have any the following documentation, within 180 days of randomization of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days，OR iii. physician note of persistent continuous AF for \> 7 days
- The duration of AF lasting ≥ 1 year
Exclusion
- PaAF or PeAF with duration \< 1 year
- has received catheter ablation procedure for AF or atrial septal defect repair before enrollment
- left atrial diameter ≥55 mm or thrombosis in the left atrium
- eGFR\<30mL/min/1.73m2
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack)
- acute or severe systemic infection
- refused to participate in this trial; or those who have participated in other clinical drug trials within 3 months prior to enrollment
- congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio \> 1.5 or partial activated prothrombin time prolonged by ≥ 10 seconds, or plasma prothrombin time prolonged by ≥ 3 seconds, or fibrinogen ≤ 1.5 g/L), or active bleeding
- pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
- life expectancy \< 12 months
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06952023
Start Date
June 1 2025
End Date
October 1 2027
Last Update
April 30 2025
Active Locations (3)
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1
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China, 210029
2
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
3
The Affiliated Hospital Of Medical School Of Ningbo University
Ningbo, Zhejiang, China, 315211