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临床试验/NCT04645342
NCT04645342已完成不适用

Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Time to Achieve First Transseptal Puncture

研究概览

简要总结

This is a randomized controlled trial examining whether Baylis's Versacross RF wire versus the conventional Baylis RF needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by time to successful transseptal puncture, during cardiac ablation procedures.

详细描述

The transseptal puncture is one of the most commonly performed procedures in the cardiac electrophysiology and interventional cardiology laboratories. Indeed, every atrial fibrillation ablation, now the predominant electrophysiology procedure performed throughout the world, routinely involves two different transseptal puncture procedures. The investigators previously performed a randomized, comparative effectiveness trial demonstrating the superiority (in both efficacy and safety) of a radiofrequency (RF) transseptal needle versus the conventional sharp-tipped mechanical needle. More recently, an alternative approach to transseptal puncture has been FDA approved and is already utilized as part of standard of care in these procedures. With this new approach, a J-shaped wire that can transmit RF energy is advanced inside the transeptal sheath rather than the more stiff RF or conventional needle. As advancing a wire is usually a step employed in any transseptal procedure (then usually requiring removal of that wire and then placement of the needle), this new approach saves a step. In addition once the wire has been advanced across the intra-atrial septum into the left atrium, the wire can be used to avoid potentially severe complications; specifically, after a transseptal needle is advanced across the left atrium, advancing the sheath over the needle can result in a sudden jump of all the equipment, risking perforation of the far left atrial wall. With the wire approach, the wire can be safely advanced into a pulmonary vein so that even if the sheath and dilator jump suddenly across the septum, they will be guided along the wire and thereby avoid perforation. The investigators will be studying patients undergoing a catheter ablation procedure at University of California, San Francisco.

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
Single (Participant)

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

  • Age ≥ 18 years old
  • Patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency ablation catheters for atrial fibrillation or atrial flutter ablation procedures at UCSF
  • Willing and able to provide written informed consent in English
  • Willing and able to comply with scheduled remote follow-up visits through 1 Year post-operative

排除标准

  • Presence of a patent foramen ovale closure device or atrial septal defect closure device
  • Cryoballoon ablation
  • IVC filter
  • Deemed not suitable by study personnel

结局指标

主要结局

Time to Achieve First Transseptal Puncture

时间窗: 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)

First transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median time in minutes to completion of the first transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as the outcome.

次要结局

  • Time to Achieve Second Transseptal Puncture(0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal))
  • Number of Participants With Equipment Exchanges((0-8 hours) duration of cardiac ablation procedure)
  • Combined Transseptal Time(0-60 minutes (summation of first transseptal and second transseptal times))
  • Fluoroscopy Time(0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal))
  • Complication Rates(complications were assessed during the duration of cardiac ablation procedure (up to 8 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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