Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PVI durability at three months
研究概览
简要总结
Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module).
Primary hypothesis: High durability of PVI is achievable with minimal fluoroscopy PVI, using ICE-guided transseptal puncture and Farapulse system.
Study Design: Single-center, prospective, single-arm study. Investigator-initiated study.
Research period, expected enrollment rate: The planned research period starts in the third quarter of 2024. The expected enrollment rate is 4 patients/week. The enrollment and performance of the index procedure are expected to be completed within 1.5 - 2 months, and then three more months are required before the remap procedure.
Procedure: Standard PVI using Farapulse system and Faraview module. Follow-up: Invasive left atrial remap 3 months after the procedure. Imaging: CT and MRi scans to detect pulsed-field ablation scars before the FU procedure.
Endpoints:
-
Primary endpoint: PVI durability at three months, detected by invasive left atrial remap, on a per PV basis.
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Secondary endpoints:
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Continuity and size of the scar caused by the index ablation, detected on the cardiac MRI and CT before the remap (to compare it with the remapping data)
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Door-to-door time (total time spent in the EP lab)
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Skin-to-skin procedure time: time from the first femoral vein puncture to the removal of all sheaths
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Left atrial dwelling time: time from inserting the long sheath in the left atrium to the sheath removal from the left atrium
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Ablation time: time from the first until the last ablation
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Fluoroscopy time and dose
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Occurrence of any adverse events related to the procedure during the hospital stay at the 3 months remap the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic paroxysmal AF
- •Age >18 years
- •Willingness to sign the informed consent form
排除标准
- •Contraindication to ablation
- •Contraindication of long-term anticoagulation
- •Persistent AF
- •History of typical or atypical flutter
- •History of PVI
- •History of cardiac surgery
- •Contraindication of cardiac MRi examination
- •Pregnancy
- •Active malignancy
- •Life expectancy <1 year
- •Valvular AF
- •Reversible cause of AF (e.g. hyperthyroidism).
研究组 & 干预措施
Ablation
Single-arm
干预措施: catheter ablation (Device)
结局指标
主要结局
PVI durability at three months
时间窗: 3 months
At three months, we perform an invasive left atrial remap. The primary outcome will be pulmonary vein reconnection. The outcome measure will be the risk (incidence) of pulmonary vein reconnection. The number of reconnected pulmonary veins will be collected.
次要结局
未报告次要终点