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Use of "iSuite" During CMR-guided Electrophysiological Procedures

2023年2月2日更新者：S.M. Chaldoupi、Academisch Ziekenhuis Maastricht

Prospective Use of Philips "iSuite" Electroanatomical Mapping System in Addition to Standard CMR-guided Electrophysiological Procedures

The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP).

研究概览

地位

招聘中

条件

心律失常

干预/治疗

其他：Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Marisevi Chaldoupi
电话号码：+31 43 387 7223
邮箱：marisevi.chaldoupi@mumc.nl

研究联系人备份

姓名：Miranda Bijvoet
电话号码：+31 43 387 7223
邮箱：miranda.bijvoet@mumc.nl

学习地点

荷兰
- Limburg
  - Maastricht、Limburg、荷兰、6202 AZ
    - 招聘中
    - Maastricht UMC+
    - 副研究员：
      
      K Vernooy, Prof. dr.
    - 副研究员：
      
      G.P Bijvoet, MD
    - 副研究员：
      
      R.J Holtackers, Ir
    - 副研究员：
      
      S.J.M. van Kuijk, MD, PhD
    - 副研究员：
      
      J.E Wildberger, Prof. dr.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study will include all eligible patients who are already scheduled and thus eligible for CMR-guided electrophysiological procedure for the treatment of a cardiac rhythm disturbance in the MUMC+, albeit meeting the in- and exclusion criteria.

描述

Inclusion Criteria:

Already scheduled by the treating electrophysiologist for CMR-EP as standard care for the treatment of a cardiac arrhythmia.
Minimum age of 18 years old.
Written informed consent

Exclusion Criteria:

Participation in another investigational study that has not reached its primary endpoint.
Contraindication for MRI such as: metallic implant, body weight > 130 kg, pregnancy, breast feeding women, known severe allergy to gadolineum contrast agents, renal failure with eGFR ≤ 30 mL/min/1,73m2.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

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
The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP 大体时间：Periprocedural	To establish whether the visualization by iSuite is correct we will compare the location visualized by the EAM with the reference images as produced by the default cine MRI sequences at the target ablation location just prior to the RF ablation. The definition of correct visualization is: good agreement between the two modalities (EAM and cine MRI) based on visual assessment of the treating electrophysiologist and the supervising CMR expert. When no consensus is reached than the visualization is coded 'incorrect'. This outcome will be dichotomized and coded as 'correct visualization' or 'incorrect visualization'. This categorical variable will be expressed as counts and proportion with 95% confidence interval (CI).	Periprocedural

次要结果测量

结果测量	措施说明	大体时间
Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure: 大体时间：Periprocedural	Anatomical confirmation of a complete ablation lesion is defined as a continuous line of high signal intensity at the target location on the edema and fibrosis sequences of the CMR at the end of the procedure. This anatomical confirmation will be judged by the CMR expert that is present during the procedure and thus will not be blinded to the EP results. Procedural success and procedural complications will be reported as count and proportion with 95% CI.	Periprocedural
Procedural time 大体时间：Periprocedural	To investigate the procedure-by-procedure change in procedural times and total amount of CMR images needed until application of the first ablation lesion	Periprocedural
Complication rate 大体时间：Periprocedural	To investigate the complication rate of CMR-EP with the integration of iSuite.	Periprocedural

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Academisch Ziekenhuis Maastricht

调查人员

首席研究员：S.M. Chaldoupi、Maastricht UMC+
首席研究员：Casper Mihl、Maastricht UMC+
学习椅：J.E Wildberger, Prof. Dr、Maastricht UMC+

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Hilbert S, Sommer P, Gutberlet M, Gaspar T, Foldyna B, Piorkowski C, Weiss S, Lloyd T, Schnackenburg B, Krueger S, Fleiter C, Paetsch I, Jahnke C, Hindricks G, Grothoff M. Real-time magnetic resonance-guided ablation of typical right atrial flutter using a combination of active catheter tracking and passive catheter visualization in man: initial results from a consecutive patient series. Europace. 2016 Apr;18(4):572-7. doi: 10.1093/europace/euv249. Epub 2015 Aug 27.
Paetsch I, Sommer P, Jahnke C, Hilbert S, Loebe S, Schoene K, Oebel S, Krueger S, Weiss S, Smink J, Lloyd T, Hindricks G. Clinical workflow and applicability of electrophysiological cardiovascular magnetic resonance-guided radiofrequency ablation of isthmus-dependent atrial flutter. Eur Heart J Cardiovasc Imaging. 2019 Feb 1;20(2):147-156. doi: 10.1093/ehjci/jey143.
Harrison J WS, Krueger S, Koken P, O'Neill M, Schaeffter T, Razavi R. Real-time magnetic resonance-guided radiofrequency atrial ablation: visualization of lesion formation and activation mapping. Heart Rhythm. 2013;10.
Lichter J, Kholmovski EG, Coulombe N, Ghafoori E, Kamali R, MacLeod R, Ranjan R. Real-time magnetic resonance imaging-guided cryoablation of the pulmonary veins with acute freeze-zone and chronic lesion assessment. Europace. 2019 Jan 1;21(1):154-162. doi: 10.1093/europace/euy089.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月4日

初级完成 (预期的)

2024年6月1日

研究完成 (预期的)

2024年12月1日

研究注册日期

首次提交

2021年1月18日

首先提交符合 QC 标准的

2021年1月26日

首次发布 (实际的)

2021年1月27日

研究记录更新

最后更新发布 (实际的)

2023年2月3日

上次提交的符合 QC 标准的更新

2023年2月2日

最后验证

2023年2月1日