大小可调冷冻球囊与传统冷冻球囊治疗阵发性心房颤动的随机对照试验：CONTRAST CRYO II 试验原理与设计

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Heart Rhythm O2 Pub Date : 2024-05-01 DOI:10.1016/j.hroo.2024.04.006

Iwanari Kawamura MD , Shinsuke Miyazaki MD, FHRS , Yukihiro Inamura MD , Junichi Nitta MD , Atsushi Kobori MD , Kohki Nakamura MD , Masato Murakami MD , Tomofumi Nakamura MD , Osamu Inaba MD , Yukio Sekiguchi MD , Sou Asano MD , Yasuhiro Sasaki MD , Shingo Mizuno MD , Shigeto Naito MD , Akihiro Hirakawa PhD , Tetsuo Sasano MD

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引用次数: 0

摘要

背景采用冷冻球囊技术进行肺静脉隔离（PVI）是一种治疗房颤（AF）的成熟疗法。本研究旨在进行一项随机临床试验，评估这种新型冷冻球囊与传统冷冻球囊相比的安全性和有效性。方法 CONTRAST-CRYO II 试验是一项多中心、前瞻性、开放标签、随机对照试验，214 名阵发性房颤患者将按照 1:1 的比例随机接受传统冷冻球囊（Arctic Front AdvanceTM Pro）或尺寸可调冷冻球囊（POLARx FIT）的冷冻球囊消融术。该研究已获得所有研究机构的机构审查委员会批准，并已在 UMIN 临床试验注册中心注册（UMIN000052500）。结果该研究的主要终点是膈神经损伤的发生率。次要终点包括手术成功率、12 个月的慢性成功率、手术相关不良事件、每个肺静脉 (PV) 应用期间的生物生理参数、手术和透视总时间、PVI 水平和隔离区域以及非 PV 病灶引发房颤的概率。该试验的结果将为阵发性房颤患者提供更多有关可调节大小的冷冻球囊隔离上皮层疗效的实用数据。

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A randomized controlled trial of the size-adjustable cryoballoon vs conventional cryoballoon for paroxysmal atrial fibrillation: The CONTRAST-CRYO II trial rationale and design

Background

Pulmonary vein isolation (PVI) with cryoballoon technology is a well-established therapy for treatment of atrial fibrillation (AF). Recently, a size-adjustable cryoballoon (POLARx^TM FIT) that enables delivery in a standard 28-mm or an expanded 31-mm size was introduced.

Objective

The purpose of this study was to perform a randomized clinical trial to evaluate the safety and efficacy of this novel cryoballoon compared to the conventional cryoballoon.

Methods

The CONTRAST-CRYO II trial is a multicenter, prospective, open-label, randomized controlled trial in which 214 patients with paroxysmal AF will be randomized 1:1 to cryoballoon ablation with either a conventional cryoballoon (Arctic Front Advance^TM Pro) or a size-adjustable cryoballoon (POLARx FIT). The study was approved by the Institutional Review Boards at all investigational sites and has been registered in the UMIN Clinical Trials Registry (UMIN000052500).

Results

The primary endpoint of this study will be the incidence of phrenic nerve injury. Secondary endpoints include procedural success, chronic success through 12 months, procedure-related adverse events, biophysiological parameters during applications for each pulmonary vein (PV), total procedural and fluoroscopy times, level of PVI and isolation area, and probability of non-PV foci initiating AF.

Conclusion

The CONTRAST-CRYO II trial is a multicenter, prospective, randomized controlled trial designed to assess the safety and efficacy of the POLARx FIT vs the Arctic Front Advance Pro. The findings from this trial will provide additional utility data on the efficacy of the size-adjustable cryoballoon for isolating PVs in patients with paroxysmal AF.

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