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

Launched by THE FIRST AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIVERSITY · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat persistent atrial fibrillation (PeAF), which is a heart condition where the heart beats irregularly and can cause symptoms like palpitations or fatigue. The trial will compare two methods of ablation, which is a procedure to help restore a normal heartbeat. One method uses pulsed field energy to create a modified Maze pattern inside both sides of the heart, while the other method focuses only on isolating the pulmonary veins. The main goal is to find out if the first method is more effective at stopping the irregular heart rhythms from returning.

To be eligible for this trial, participants must be between 18 and 75 years old and have been diagnosed with symptomatic PeAF for at least a year. They should also have evidence of ongoing atrial fibrillation from recent heart monitoring. Participants will be randomly assigned to one of the two treatment groups and will undergo follow-up checks at 3, 6, 9, and 12 months after the procedure to see how well the treatment worked. It's important to note that this trial is not yet recruiting participants, and there are specific health conditions that may exclude someone from participating.

Gender

ALL

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