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临床试验/NCT05560204
NCT05560204Enrolling By Invitation不适用

Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet: A Randomized Controlled Study

Prince of Wales Hospital, Shatin, Hong Kong2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
2
主要终点
Rate of >=moderate peri-device leak (i.e. >=3mm) on follow-up TEE

研究概览

简要总结

AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation. Oral anticoagulant (OAC) therapy is currently the standard therapy before and after successful ablation. Percutaneous LAA Occlusion (LAAO) has been emerged as an alternative to oral anticoagulants for stroke prophylaxis in patients who refused or contraindicated to OAC. As both AF ablation and percutaneous LAAO require transseptal access from to left atrium, combining the two procedures into one single procedure may provide a straightforward strategy aiming at concomitant rhythm control as well as stroke prevention, without the additional risk of multiple procedures. It is showed in previous studies that this approach is feasible and safe.

Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses high amplitude pulsed electrical fields to ablate tissues through the mechanism of irreversible electroporation. Irreversible electroporation is the application of high electric field to a cell with a resultant increased permeability of the membrane and downstream cell death. Success with PFA depends upon the proximity of the electrode to the target tissue, but not necessarily upon contact. Therefore, with PFA the transseptal access for successful AF ablation is less demanding. Moreover, PFA would induce less pulmonary ridge edema compared to conventional ablation techniques and could potentially causes less PDL. Watchman Flx (Boston Scientific) and Amulet (Abbott) are the two most commonly used LAAO devices. The two devices have different designs, deployment requirements and occlusion results. Both devices have been used in combined procedure. However, there is no data of combined AF ablation and LAAO using the PFA technique, and of combined AF ablation comparing the use of Watchman Flx versus Amulet device.

In this randomized controlled study, we aim to assess the feasibility and compare the peri-procedural outcomes and LAA occlusion result of combined AF ablation (using the PFA technique), and LAAO using either the Watchman Flx or the Amulet device.

详细描述

Atrial fibrillation (AF) is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality. AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation. Oral anticoagulant (OAC) therapy is currently the standard therapy before and after successful ablation. Percutaneous LAA Occlusion (LAAO) has been emerged as an alternative to oral anticoagulants for stroke prophylaxis in patients who refused or contraindicated to OAC . As both AF ablation and percutaneous LAAO require transseptal access from to left atrium, combining the two procedures into one single procedure may provide a straightforward strategy aiming at concomitant rhythm control as well as stroke prevention, without the additional risk of multiple procedures. It is showed in previous studies that this approach is feasible and safe. However, the current AF ablation techniques (radiofrequency ablation and cryoballoon ablation) requires a less posterior transseptal access while LAAO requires a posterior-inferior transseptal access. This could potentially make LAAO after same procedure AF ablation using the same transseptal access more challenging. Besides, current ablation techniques would induce edema over pulmonary ridge, which could potentially result in significant peri-device leak (PDL) post LAAO after edema subsided. Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses high amplitude pulsed electrical fields to ablate tissues through the mechanism of irreversible electroporation. Irreversible electroporation is the application of high electric field to a cell with a resultant increased permeability of the membrane and downstream cell death. Success with PFA depends upon the proximity of the electrode to the target tissue, but not necessarily upon contact. Therefore, with PFA the transseptal access for successful AF ablation is less demanding. Moreover, PFA would induce less pulmonary ridge edema compared to conventional ablation techniques and could potentially causes less PDL. Watchman Flx (Boston Scientific) and Amulet (Abbott) are the two most commonly used LAAO devices. The two devices have different designs, deployment requirements and occlusion results. Both devices have been used in combined procedure. However, there is no data of combined AF ablation and LAAO using the PFA technique, and of combined AF ablation comparing the use of Watchman Flx versus Amulet device. In this randomized controlled study, we aim to assess the feasibility and compare the peri-procedural outcomes and LAA occlusion result of combined AF ablation (using the PFA technique), and LAAO using either the Watchman Flx or the Amulet device.

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
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Paroxysmal or persistent non- valvular atrial fibrillation
  • CHADS2-VASc >=2
  • Age >=18; and able to give written consent

排除标准

  • are in permanent atrial fibrillation
  • are not eligible for 3 months of oral anticoagulant post ablation
  • has left Atrial thrombus identified by pre-procedure TEE or during procedure
  • had received prior left atrial appendage closure procedure (percutaneous or surgical)
  • are planned to receive concomitant ablation procedure or structural heart interventions other than AF ablation and LAAO (e.g SVT ablation, Aflutter ablation, PFO closure, leadless pacemaker, ASD Closure, etc)
  • patient whom refused or cannot tolerate procedural or post procedural follow-up TEE

结局指标

主要结局

Rate of >=moderate peri-device leak (i.e. >=3mm) on follow-up TEE

时间窗: 45-90 days

Rate of \>=moderate peri-device leak (i.e. \>=3mm) on follow-up TEE

次要结局

  • LAAO technical success rate(Baseline)
  • Number of device used(baseline, 45-90 days, 6-months, 12-months)
  • PFA acute technical success(baseline, 45-90 days, 6-months, 12-months)
  • Number of Participants with 1-year clinical events(baseline, 45-90 days, 6-months, 12-months)
  • Rate of procedural related complications(baseline, 45-90 days, 6-months, 12-months)
  • Total ablation time(baseline, 45-90 days, 6-months, 12-months)
  • LAAO procedural time(baseline, 45-90 days, 6-months, 12-months)
  • Number of device recapture (full or partial)(baseline, 45-90 days, 6-months, 12-months)
  • Need of additional transseptal puncture for LAAO(baseline, 45-90 days, 6-months, 12-months)
  • AF ablation procedural success(baseline, 45-90 days, 6-months, 12-months)

研究者

发起方
Prince of Wales Hospital, Shatin, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr So Chak Yu kent

Principle Investigator

Prince of Wales Hospital, Shatin, Hong Kong

研究点 (2)

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