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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Modified Maze ablation with PFA
Procedure/SurgeryModified Maze ablation with PFA
PVI only with PFA
Procedure/SurgeryPVI only with PFA
Treatment groups
390 Participants
are divided into 2 treatment groupsGroup A: PF-based modified Maze ablationExperimental treatment 1 intervention
Group B: RF-based PVI onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from atrial tachycardia during blanking period to Month 12
freedom of occurrence ≥ 30 sec of Atrial Fibrillation (AF), Atrial Flutter (AFL), atrial Tachycardia (AT); or any electrical cardioversion or re-ablation for AF, AFL, or AT; or any Class I or III AAD use
Time frame
during blanking period to Month 12Secondary outcomes
1
Acute Success - Isolation rate of attempted pulmonary veins and left atrial linear ablation
Isolation rate of attempted pulmonary veins and left atrial linear ablation
Time frame
intraprocedure2
device or procedure-related Composite Adverse Events
device or procedure-related Composite Adverse Events including Heart block, Myocardial infarction, Peripheral or organ thromboembolism, Stroke/ Cerebrovascular accident/Transient ischemic attack (TIA),Unresolved phrenic nerve palsy / paresis,Vascular access complications
Time frame
day 0 to 12 months3
procedure time
procedure time
Time frame
intraprocedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: