临床试验/NCT07809347

NCT07809347招募中不适用

Evaluation of the Factors Associated With Bradtycardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation

Wroclaw Medical University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2026年1月1日最近更新: 2026年9月9日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 100
试验地点: 1
主要终点: Sinus bradycardia <50 beats/min on arrival at the recovery unit, defined as a sinus heart rate <50 beats/min on the first ECG obtained upon arrival

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.

详细描述

The following factors will be analyzed:

demographics
medical history
medications
echocardiographic data
baseline ECG
anaesthetic records
periprocedural data

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•- Pulmonary vein isolation performed with PFA

排除标准

•Permanent pacemaker
•CRT device
•Dual-chamber ICD
•Cardiac tamponade
•Acute stroke
•Acute bleeding requiring surgical intervention

结局指标

主要结局

Sinus bradycardia <50 beats/min on arrival at the recovery unit, defined as a sinus heart rate <50 beats/min on the first ECG obtained upon arrival

时间窗: Day 1

次要结局

Bradycardia requiring medical intervention(Day 1)
Sinus bradycardia <50 beats/min, defined as a sinus heart rate <50 beats/min on the ECG obtained the next day after ablation(Day 2)

研究者

发起方

Wroclaw Medical University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Piotr Niewinski, MD

Doctor

Wroclaw Medical University

研究点 (1)

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