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临床试验/NCT05988424
NCT05988424尚未招募不适用

Randomised Comparison of the Octaray and Pentaray Catheters

University Hospital Southampton NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Time to collect left atrial geometry

研究概览

简要总结

In this study we aim to compare the mapping performance in the left atrium of the established Pentaray catheter to the newer Octaray catheter.

详细描述

Compared with conventional point by point mapping, the use of a multipolar high density Pentaray catheter (Biosense Webster, Diamond Bar, CA, USA) has been found to produce more rapid, accurate maps. This catheter has 20, 2mm2 electrodes. Newer, high density mapping catheters have also been introduced, capable of collecting detailed maps rapidly. Such catheters include the Orion catheter (Boston Scientific, Marlborough, MA, USA) which has 64, 0.4mm2 electrodes and has been shown to be safe and effective in real world usage, and the HD Grid (Abbott Cardiovascular, Lake Forest, IL, USA) which has 16, 1mm electrodes and has been shown to be associated with shorter procedure and fluoroscopy times and better success rates than conventional circular mapping catheters when used for AF ablation.

Of the above high density catheters, the Pentaray is integrated into the Carto3 system. An advantage of this platform for mapping is the ability to use the Tissue Proximity Indicator (TPI) Filter to reduce the number of points collected without contact and improve the accuracy of the subsequent voltage map.

A novel multipolar catheter, iterating on the previous Pentaray catheter is now being introduced: Octaray. This has 48, 0.9mm2 electrodes arranged on 8 splines. In preclinical studies, Octaray has been found to be collect maps faster, at higher density and with greater accuracy for conduction gaps than the Pentaray. The new catheter has been used safely in clinical cases.

Methods This is a randomised, prospective, single centre, interventional study, Thirty patients listed for redo AF ablation procedures on clinical grounds will be included in the study. Procedures will be under conscious sedation or general anaesthetic as per the preference of the operator, as will the mode of transeptal access and sheaths used to deliver the mapping catheter to the left atrium.

At the start of the case, two consecutive LA maps will be taken by the same operator using the Pentaray and Octaray catheters. In both cases, throughout the study the same catheter types will be used. For the Pentaray catheter, this will be the standard 4-4-4 spaced version. The Octaray for the study will be the larger, 20mm spline version, with the 3-3-3-3-3 spacing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The patient will not be aware which mapping catheter they are randomised to have used in their case first.

The data will be processed for analysis blinded to the catheter used to collect the map

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

  • Patients >18 years listed for redo AF ablation on clinical grounds GA or LA/sedation cases

排除标准

  • Age <18 years Pregnancy Unable or unwilling to consent Mechanical mitral valve Replacement Enrolled in another clinical study that could confound the results of this study (note: patients enrolled in complementary study are eligible for enrolment)

结局指标

主要结局

Time to collect left atrial geometry

时间窗: 1 year

Time to collect left atrial geometry

次要结局

  • Map point density(1 year)
  • Time to start point collection, based on fulfilment of TPI criteria(1 year)
  • Low voltage area comparison(1 year)
  • Number and size of PVI gaps identified(1 year)
  • Volume of LA geometry(1 year)

研究者

申办方类型
Other
责任方
Sponsor

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