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临床试验/NCT05396534
NCT05396534招募中不适用

Personalized Persistent Atrial Fibrillation Ablation: The PeAF-BY-LAWT Trial

Centro Medico Teknon2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
156
试验地点
2
主要终点
Arrhythmia-free survival

研究概览

简要总结

The investigators hypothesized that PeAF-by-LAWT, a personalized protocol that uses a contact-force catheter, a multichannel radiofrequency (RF) generator, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol for persistent AF ablation.

详细描述

Pulmonary vein isolation (PVI) remains the cornerstone of all catheter-based treatment strategies in atrial fibrillation (AF). Currently, PVI is recommended (class IA indication) after one failed or intolerant class I or III antiarrhythmic drug (AAD) to improve symptoms, either in paroxysmal (PaAF) or persistent AF (PeAF). However, PVI can be also considered as first-line treatment to achieve rhythm control, particularly in cases when tachycardia-induced cardiomyopathy is suspected, a circumstance likely more related to a higher AF burden or PeAF.

PVI has been proven to be effective in treating PeAF, although long-term ablation outcomes have been significantly less satisfactory than in PaAF. In a recent metaanalysis, PVI in PeAF achieved an arrhythmia-free survival at 12 months of 66.7%, with > 80% of the patients off AAD. Other ablation strategies combining PVI plus additional substrate ablation (linear ablation and/or complex fractionated atrial electrogram ablation) have been unable to demonstrate better outcomes than PVI-alone.

On the other hand, recent advances both in technology and ablation protocols have resulted in greatly improved outcomes after PVI. The introduction of contact force-sensing catheters, novel estimates of lesion size [ablation index (AI) or lesion size index, and the fact of ensuring lesion contiguity (≤ 6 mm inter-lesion distance) have markedly improved arrhythmia-free survival after PVI, particularly in PaAF.

The CLOSE clinical study analyzed the utility of ablation index (AI), a novel formula developed to assess real-time effect of RF delivery and improve the rates of PVI, with 91.3% of the patients free from AF/AT/atrial flutter (AFL) at 12 months follow-up. The CLOSE protocol targeted an interlesion distance (ILD) of 6 mm and AI ≥ 400 at the posterior wall and ≥550 at the anterior wall. Recently, Hussein et al. demonstrated that the use of AI-guided PVI alone performed with radiofrequency energy in a point-by-point wide area circumferential ablation (WACA) pattern according to CLOSE protocol achieves good clinical outcomes in persistent AF patients at 12 months follow-up. Finally, a more recent, personalized PVI strategy, aiming for contiguous lesions with AI titration according to the local left atrial wall thickness (LAWT) as per multidetector cardiac tomography (MDCT), has demonstrated to achieve an arrhythmia-free survival > 95% at 12 months in PaAF.

Up to date, there are no randomized studies for persistent AF ablation comparing the outcomes of PVI-alone procedures performed with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT), compared with the CLOSE protocol.

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
Double (Participant, Care Provider)

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.
  • Indication for persistent atrial fibrillation ablation.
  • Signed informed consent

排除标准

  • Age < 18 years.
  • Pregnancy.
  • Previous AF redo procedure.
  • Impossibility to perform a pre-procedural CT scan.
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

结局指标

主要结局

Arrhythmia-free survival

时间窗: After the 3-month 'blanking period' for 12 month

The efficacy primary endpoint will be survival free of any atrial arrhythmia at12-month follow-up visits. From this endpoint, important definitions must be taken into account: AF clinical recurrence will be considered only after the 3-month 'blanking period'.

次要结局

  • Procedure time(intraprocedural outcome)
  • Number of application(intraprocedural outcome)
  • Radiofrequency time(intraprocedural outcome)

研究者

发起方
Centro Medico Teknon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Berruezo, MD, PhD

Head of Arrhythmia Department

Centro Medico Teknon

研究点 (2)

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