氟卡尼预防卵圆孔未闭封堵术后房性心律失常：随机 AFLOAT 研究的原理和设计。

Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study.

机构信息

Université de Versailles-Saint Quentin, INSERM U1018, CESP, ACTION Study Group, Department of Cardiology, Ambroise Paré Hospital (AP-HP), 92100 Boulogne, France.

Sorbonne Université, ACTION Study Group, INSERM UMRS1166, ICAN-Institute of CardioMetabolism and Nutrition, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), 75013 Paris, France.

出版信息

Eur Heart J Cardiovasc Pharmacother. 2024 May 4;10(3):184-189. doi: 10.1093/ehjcvp/pvad100.

DOI:10.1093/ehjcvp/pvad100

PMID:38216511

Abstract

INTRODUCTION

Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown.

METHODS/DESIGN: The Assessment of Flecainide to Lower the PFO closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150 mg per day in a single sustained-release (SR) dose) for 6 months (Group 1), Flecainide (150 mg per day in a single SR dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30 s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analysed as a secondary objective of the study.

CONCLUSION

AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure.

CLINICAL TRIAL REGISTRATION

NCT05213104 (clinicaltrials.gov).

摘要

简介

房间隔缺损（PFO）封堵术后最常见的并发症是房性心律失常。PFO 封堵术后房性心律失常的真实发生率以及该并发症是否可以预防尚不清楚。

方法/设计：评估氟卡尼降低卵圆孔未闭封堵后房颤或心动过速风险（AFLOAT）试验是一项前瞻性、全国性、多中心、随机、开放标签、优效性试验，所有终点均采用盲法评估（PROBE 设计）。186 例患者在 PFO 封堵后立即以 1:1:1 的比例随机分为三组：封堵后即刻给予氟卡尼（每天 150mg 单次持续释放（SR）剂量）6 个月（第 1 组）、氟卡尼（每天 150mg 单次 SR 剂量）3 个月（第 2 组）或不进行额外治疗（标准护理）6 个月（第 3 组）。主要终点是在植入式心脏监测仪进行的长期监测下，3 个月内至少有 1 例症状性或无症状性房性心律失常（≥30s）的患者比例。该研究的次要目标是分析 3 个月治疗与 6 个月治疗相比是否足够。