跳至主要内容
临床试验/NCT06007872
NCT06007872招募中不适用

Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance

研究概览

简要总结

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

详细描述

Left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use of oral anticoagulants.

Concurrent procedural TEE is an integral part of the procedure. It is used to guide trans-septal puncture, device sizing and assessment of final adequacy of device implant.

TEE requires the participation and guidance of a cardiac imager and because the TEE probe is in place for a relatively long duration the procedure, the procedure is most commonly performed under general anesthesia. Furthermore TEE can be associated with risk of injury to the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest that TEE may not be necessary for the overall success of the procedure. The objective of the study is to investigate a new work flow that may ultimately demonstrate that intra-procedural TEE may not be necessary, obviating the need for additional personnel, general anesthesia and decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize left atrial anatomy. Smaller studies and case series have reported the use of ICE as an alternative to TEE in guiding Watchman device implant. This has not been compared systematically with TEE in a large patient sample.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial

排除标准

  • Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
  • Patients receiving a concomitant ablation procedure
  • Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
  • Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).

结局指标

主要结局

Successful Watchman implantation using intracardiac echocardiography (ICE) guidance

时间窗: During the procedure

Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oussama Wazni

Principal Investigator

The Cleveland Clinic

研究点 (2)

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