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

NCT06952023 | Not Yet Recruiting

• 1 other identifier: maze001
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 3

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.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.

Conditions

Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

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

  during blanking period to Month 12

Secondary Outcomes (3)

• Acute Success - Isolation rate of attempted pulmonary veins and left atrial linear ablation

  intraprocedure

• device or procedure-related Composite Adverse Events

  day 0 to 12 months

• procedure time

  intraprocedure

Study Arms (2)

PF-based modified Maze ablation

EXPERIMENTAL

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.

Procedure: Modified Maze ablation with PFA

RF-based PVI only

ACTIVE COMPARATOR

PVI only with PF energy

Procedure: PVI only with PFA

Interventions

Modified Maze ablation with PFA PROCEDURE

Modified Maze ablation with PFA

PF-based modified Maze ablation

PVI only with PFA PROCEDURE

PVI only with PFA

RF-based PVI only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (3)

Jiangsu Provincial Hospital

Nanjing, Jiangsu, 210029, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

The Affiliated Hospital Of Medical School Of Ningbo University

Ningbo, Zhejiang, 315211, China

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Desmoglein 1

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens

Central Study Contacts

Xiaomeng Yin, Ph.D

CONTACT

+86 18098875778; dr.yinxm@163.com

Chengming Ma, MD

CONTACT

+86 18098875759; machengming@dmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (3)