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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| RF-based PVI only | Active Comparator | PVI only with PF energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Maze ablation with PFA | Procedure | Modified Maze ablation with PFA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Success - Isolation rate of attempted pulmonary veins and left atrial linear ablation | Isolation rate of attempted pulmonary veins and left atrial linear ablation | intraprocedure |
| device or procedure-related Composite Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomeng Yin, Ph.D | Contact | +86 18098875778 | dr.yinxm@163.com | |
| Chengming Ma, MD | Contact | +86 18098875759 | machengming@dmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Hospital | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39567904 | Background | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D051183 | Desmoglein 1 |
| ID | Term |
|---|---|
| D051182 | Desmogleins |
| D051181 | Desmosomal Cadherins |
| D015820 | Cadherins |
| D015815 | Cell Adhesion Molecules |
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| PVI only with PFA | Procedure | PVI only with PFA |
|
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
| day 0 to 12 months |
| procedure time | procedure time | intraprocedure |
| First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
|
| The Affiliated Hospital Of Medical School Of Ningbo University | Ningbo | Zhejiang | 315211 | China |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008562 |
| Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D001324 | Autoantigens |