PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF

Official title

Pulsed Field-Based Bi-atrial Maze-like Catheter Ablation Versus Pulmonary Vein Isolation in Persistent Atrial Fibrillation: A Multi-center Randomized Controlled Trial

Overview

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.

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 only) in a 1:1 ratio. In the study group, patients will receive PF energy based PVI, BOX ablation, LA anterior wall linear ablation from the right superior pulmonary vein to the mitral annulus (under sinus rhythm), MI ablation, linear ablation of the RA posterior wall (up to the superior vena cava and down towards the inferior vena cava according to the potential), and CTI ablation. The patients in the control group will received PVI only with PF energy. If the patients do not restore to sinus rhythm, they will receive electrical cardioversion.

All patients received guideline-directed standardized drug therapy, including anti-arrhythmic medications, postoperatively. Discontinuation of all anti-arrhythmic drugs after the blanking period. 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.

Interventions

• Procedure Modified Maze ablation with PFA
  Modified Maze ablation with PFA
• Procedure PVI only with PFA
  PVI only with PFA

Primary outcome measures

• Freedom from atrial tachycardia during blanking period to Month 12 [Time frame: during blanking period to Month 12]

Secondary outcome measures (3)

• Acute Success - Isolation rate of attempted pulmonary veins and left atrial linear ablation [Time frame: intraprocedure]
• device or procedure-related Composite Adverse Events [Time frame: day 0 to 12 months]
• procedure time [Time frame: intraprocedure]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 3 centers

• Jiangsu Provincial Hospital — Nanjing
• First Affiliated Hospital of Dalian Medical University — Dalian
• The Affiliated Hospital Of Medical School Of Ningbo University — Ningbo

Publications

• Sun Y, Dai S, Xiao X, Wang Z, Yu X, Ma C, Zhang R, Gao L, Xia Y, Yin X. Tailored bi-atrial linear ablation guided by electrophysiological mapping for persistent atrial fibrillation. BMC Cardiovasc Disord. 2024 Nov 20;24(1):658. doi: 10.1186/s12872-024-04332-w. PMID 39567904

Identifiers

NCT: NCT06952023 · maze001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗