VEnous cLOsure vs. FIgRE of 8 Suture After AF Ablation: The VELOFIRE Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Post-Procedural Patient Satisfaction Score
研究概览
简要总结
This prospective, randomized, participant-blinded study will compare a suture-based venous closure system (Perclose ProGlide™) with a conventional figure-of-8 suture for femoral venous access-site closure in patients undergoing catheter ablation for atrial fibrillation. A total of 90 participants will be randomized in a 1:1 ratio to the venous closure system group or the figure-of-8 suture group. The primary objective is to evaluate patient satisfaction with the post-procedural vascular closure strategy. Secondary outcomes include time to hemostasis, time to ambulation, time to discharge, and the incidence of minor and major vascular complications within 30 days. Participants will complete a post-procedural satisfaction questionnaire after suture removal, and vascular access-site complications will be assessed during hospitalization and follow-up through 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥19 years or legal age to provide informed consent under Korean law.
- •Scheduled for atrial fibrillation catheter ablation using unilateral femoral venous access with a sheath ≥8 Fr.
- •Bilateral femoral venous anatomy suitable for application of the Perclose ProGlide™ suture-based vascular closure device.
- •Written informed consent and agreement to post-procedural follow-up and outpatient visits.
- •Considered able to complete follow-up during the study period.
排除标准
- •History of prolonged hospitalization due to vascular access-related complications.
- •History of vascular surgery involving the lower extremities or aorto-iliac axis.
- •Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state).
- •Platelet count <100,000/mm³.
- •History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis.
- •Moderate or greater anemia (hemoglobin ≤10 g/dL).
- •Hemodynamic or electrical instability.
- •Body mass index >45 kg/m² or <20 kg/m².
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.
- •1. History of prolonged hospitalization due to vascular access-related complications.
- •2. History of vascular surgery involving the lower extremities or aorto-iliac axis.
- •3. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state).
- •4. Platelet count <100,000/mm³.
- •History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis.
- •Moderate or greater anemia (hemoglobin ≤10 g/dL).
- •Hemodynamic or electrical instability.
- •Body mass index >45 kg/m² or <20 kg/m².
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.
研究组 & 干预措施
Venous Closure System
Participants will undergo standard PVI with additional patient-specific ablation targeting stable atrial fibrillation drivers identified by the digital twin model, followed by protocol-specified rhythm monitoring.
干预措施: Perclose ProGlide™ (Procedure)
Figure-of-8 Suture
Participants will undergo conventional figure-of-8 suture closure of the femoral venous access site after atrial fibrillation catheter ablation.
干预措施: Figure-of-8 suture (Procedure)
结局指标
主要结局
Post-Procedural Patient Satisfaction Score
时间窗: Periprocedural
Patient satisfaction with the vascular closure method will be assessed using the protocol-specified Post-Procedural Patient Satisfaction Questionnaire. The total score ranges from 0 to 60 points and will be compared between randomized groups.
次要结局
- Time to Hemostasis(Periprocedural)
- Time to Ambulation(Periprocedural)
- Time to Hospital Discharge(Periprocedural)
- Minor and Major Vascular Complications(Within 30 days after the index procedure)