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临床试验/NCT05836311
NCT05836311尚未招募不适用

Single Perclose Escalation Technique for Vascular Closure in TAVR

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)

研究概览

简要总结

This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

详细描述

Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years
  • Patients who have undergone Transfemoral TAVI implantation

排除标准

  • Patients who do not meet the inclusion criteria

结局指标

主要结局

SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)

时间窗: 30 days

Intrahospital Major Vascular Complications and Bleeding type 2 or type \>2 (according to VARC 3 criteria)

EFFICACY:Incidence of successful femoral closure

时间窗: 30 days

Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy

次要结局

  • Incidence of vascular complications (according to VARC3 criteria)(30 days)
  • All-cause Mortality(1 year)
  • Cost-effectiveness evaluation(30 days)
  • Incidence of bleeding (according to VARC3 criteria)(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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