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临床试验/NCT02516033
NCT02516033已完成不适用

Identification of a Risk Profile Associated With Failure of the Hybrid Ablation of Atrial Fibrillation.

University Medical Center Groningen0 个研究点目标入组 250 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
主要终点
Failure of the hybrid ablation procedure in patients with atrial fibrillation

研究概览

简要总结

Recently a combined approach of surgeon ablation in combination with endocardial ablation (hybrid ablation) has been introduced. This therapy has shown excellent results in patients with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in patients with persistent atrial fibrillation. The investigators hypothesize that the severity of atrial remodeling in patients with atrial fibrillation can be measured by clinical factors, echocardiographic parameters, circulating biomarkers and genetic background, and that these factors can be used to identify a risk profile to predict failure of the hybrid ablation therapy in patients with atrial fibrillation. Aim of this study is to determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure, in a prospective single center registry setting. The investigators evaluate all consecutive patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants. Extra study related procedures include blood sampling for biomarkers and genetic analysis, prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life questionnaire. Total follow-up will be five years.

Main study endpoint is failure of the hybrid ablation procedure in patients with atrial fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia >30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day Holter monitoring.

详细描述

Rationale: The investigators hypothesize that the severity of atrial remodeling in patients with atrial fibrillation can be measured by clinical factors, echocardiographic parameters, circulating biomarkers and genetic background, and that these factors can be used to identify a risk profile to predict failure of the hybrid ablation therapy in patients with atrial fibrillation.

Objective

To determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure in patients with atrial fibrillation.

Study design: A prospective single center registry. Study population: Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants.

Intervention: Extra study related procedures include blood sampling for biomarkers and genetic analysis at baseline and 1 year follow-up; prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/ atrial flutter/atrial tachycardias at 3 months, 6 months and 1 year follow-up; and a quality of life questionnaire at baseline, and at 1 year and 5 year follow-up.

Total follow-up duration: Five years. Main study endpoints: Failure of the hybrid ablation procedure in patients with atrial fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia >30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day Holter monitoring.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation.

排除标准

  • 未提供

结局指标

主要结局

Failure of the hybrid ablation procedure in patients with atrial fibrillation

时间窗: 1 year

Any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \>30sec without anti-arrhythmic drugs at 1 year by ECG recording and 3-day Holter monitoring.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

I.C. Van Gelder

prof.

University Medical Center Groningen

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