PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Dalian Medical University
About this trial
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.The goal of this clinical trial is to evaluate the efficiency of pulsed filed (PF) energy-based bi-atrial modified Maze ablation vs PF energy-based PVI of PeAF.
The main questions it aims to answer are:
Does PF energy effectively perform linear ablation in the left atrium? Does PFA-based bi-atrial modified Maze ablation significantly improve the success rate of PeAF ablation compared with PFA-based PVI?
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 only) in a 1:1 ratio. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Modified Maze ablation with PFA
- PVI only with PFA
Treatment groups
390 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov