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This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.
No other detailed description.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| superior vena cava isolation | Experimental | Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation and left atrial posterior wall isolation will be conducted in the experimental group. |
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| superior vena cava and left atrial posterior wall isolation | Active Comparator | Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| superior vena cava isolation | Procedure | Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month atrial fibrillation (AF) ablation success rate | Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation) | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute pulmonary vein ablation success rate and superior vena cava isolation rate. | Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage < 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GUODONG NIU | Contact | +86 0871-68279999 | guodniu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Yunnan Hospital | Kunming | Yunnan | China |
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| Abnormal left atrial substrate | Procedure | Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group. |
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| Immediately post-procedure |
| Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only) | Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage < 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing. | Immediately post-procedure |
| Procedure-related time | Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time. | Immediately post-procedure |
| Early recurrence rate of atrial arrhythmia (within the blanking period) | Early recurrence rate of atrial arrhythmia (within the blanking period) | Within 3 months post-procedure |
| Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period. | Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period | Within 12 months post-procedure |
| Incidence of repeat ablation after the blanking period | Incidence of repeat ablation after the blanking period | Within 12 months post-procedure |
| Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation. | Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation. | Within 12 months post-fist procedure. |
| Improvement in Atrial fibrillation burden. | Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography. | 3、6 and 12 months post-procedure. |
| Cardiac function assessment by NYHA | Cardiac function was assessed relative to baseline using the NYHA classification. | within 12 months post-procedure |
| The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale. | Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score. | Within 12 months post-procedure |
| 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 |
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