Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Albert Einstein College of Medicine and Montefiore Medical Center | UNKNOWN |
| Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine | UNKNOWN |
| Shandong University of Traditional Chinese Medicine |
Not provided
Not provided
Not provided
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomical Guided Ablation Group | Placebo Comparator | This group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping. |
|
| Electrogram Guided Ablation Group | Active Comparator | This group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths. |
|
| Extensive Electro-Anatomical Guided Ablation Group | Experimental | This group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extensive Electro-Anatomical Guided Ablation | Procedure | Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Arrhythmia Recurrence at 12 Months | Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation. | 12 months after ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Safety | Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis. | From enrollment to completion of follow-up（at least 12 months） |
| Symptom Relief and Quality of Life Enhancement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Liu, MD | Contact | +86 021-22200000 | drliuxu@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 241, West Huaihai Road | Shanghai | Shanghai Municipality | 200000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Yuhuan Second People's Hospital | UNKNOWN |
| Changshu Hospital of Traditional Chinese Medicine | OTHER |
| Jinan People's Hospital | UNKNOWN |
| Xuzhou Central Hospital | OTHER |
| The PLA Navy Anqing Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
| Anatomical Guided Ablation | Procedure | Ablation using PFA. Guided by anatomical landmarks without potential mapping |
|
| Electrogram Guided Ablation | Procedure | Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter. |
|
Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).
| From enrollment to completion of follow-up（at least 12 months） |
| Atrial Fibrillation Burden Reduction | Reduction in atrial fibrillation burden assessed through follow-up evaluations. | From enrollment to completion of follow-up（at least 12 months） |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided