Pulsed Field Ablation Versus Radiofrequency Ablation: Effects of Pulmonary Vein Isolation Combined With Left Atrial Posterior Wall Isolation on Postoperative Gastric Motility in Patients With Persistent Atrial Fibrillation (PFA-GM)
A Comparative Study on the Effects of Pulmonary Vein Isolation Combined With Left Atrial Posterior Wall Isolation Via Pulsed Field Ablation Versus Radiofrequency Ablation on Postoperative Gastric Motility in Patients With Persistent Atrial Fibrillation
This is a single-center, prospective, matched cohort study comparing the effect of Pulsed Field Ablation (PFA) versus Radiofrequency Ablation (RF) on postoperative gastric motility in patients with persistent atrial fibrillation (AF). A total of 20 patients will be enrolled in a 1:1 matched design (10 PFA, 10 RF), matched by age, gender, left atrial diameter, AF duration, and diabetes history. All patients will undergo pulmonary vein isolation (PVI) plus left atrial posterior wall isolation (LAPWI).
The primary outcome is gastric emptying assessed by radionuclide imaging preoperatively and at 48 hours post-ablation. Secondary outcomes include gastrointestinal symptom scores: PAGI-SYM, GSRS, and GerdQ measured before ablation and at 7 days post-procedure.
Patients with prior AF ablation, upper gastrointestinal surgery, gastroparesis, or recent use of gastrointestinal medications are excluded. The study period is from January 30, 2026 to July 30, 2026.
This study aims to evaluate whether PFA is associated with better gastric motility preservation compared with conventional RF ablation in persistent AF patients undergoing extended PVI plus posterior wall isolation.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Fu Yi
- 电话号码:+8613572100232
- 邮箱:yi12fu56@126.com
研究联系人备份
- 姓名:Zi Hao
- 电话号码:+8618220244424
- 邮箱:18220244424@163.com
学习地点
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Shaanxi
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Xi'an、Shaanxi、中国、710032
- Xijing Hospital, Air Force Medical University
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接触:
- Fu Yi
- 电话号码:+8613572100232
- 邮箱:yi12fu56@126.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18-80 years
- Diagnosed with persistent atrial fibrillation (AF) according to current guidelines
- Undergoing first-time catheter ablation (PFA or RF) with planned pulmonary vein isolation plus left atrial posterior wall isolation
- Able to understand and sign informed consent
- Able to complete radionuclide gastric emptying scintigraphy and symptom questionnaires
Exclusion Criteria:
- Previous AF ablation or cardiac surgery
- History of gastroparesis or severe gastrointestinal disease
- Prior upper gastrointestinal surgery
- Use of prokinetic or antisecretory medications within 4 weeks before enrollment
- Severe renal/hepatic dysfunction or active malignancy
- Pregnant or breastfeeding women
- Inability to comply with study procedures or follow-up
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Pulsed Field Ablation(PFA) Group
Patients with persistent atrial fibrillation who undergo pulmonary vein isolation combined with left atrial posterior wall isolation using pulsed field ablation.
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Pulmonary vein Description isolation combined with left atrial posterior wall isolation using pulsed field ablation for persistent atrial fibrillation.
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Radiofrequency Ablation(RFA) Group
Patients with persistent atrial fibrillation who undergo pulmonary vein isolation combined with left atrial posterior wall isolation using radiofrequency ablation.
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Pulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gastric Motility After Pulsed Field Versus Radiofrequency Ablation
大体时间:Preoperatively and at 48 hours post-ablation
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Gastric emptying function will be assessed by radionuclide gastric emptying scintigraphy.
The primary outcome is the difference in the percentage of gastric retention at 2 hours postprandial between the pulsed field ablation (PFA) group and the radiofrequency ablation (RF) group, measured preoperatively and at 48 hours post-ablation.
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Preoperatively and at 48 hours post-ablation
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合作者和调查者
调查人员
- 首席研究员:Fu Yi、The First Affiliated Hospital of Air Force Medicial University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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