Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Recurrent atrial fibrillation
研究概览
简要总结
The Biorhythm study aims to investigate the utility of new biomarkers (e.g. MR proANP, ST2) measured pre-procedure for the prediction of procedural success in patients with atrial fibrillation undergoing cardioversion or ablation.
详细描述
This is a prospective, observational, multicentre study of patients with paroxystic or persistent atrial fibrillation scheduled to undergo cardioversion or ablation of AF in routine practice. Serum levels of MR proANP and ST2 pre-procedure will be measured to attempt to identify a threshold that carries prognostic value for procedural success (maintenance of sinus rhythm at one year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxystic or persistent atrial fibrillation for whom a decision to perform ablation is made.
- •Patients with persistent atrial fibrillation for whom a decision to perform cardioversion is made.
- •Patients with social security coverage, or beneficiary thereof.
- •Patients who provide written informed consent.
排除标准
- •Age <18 years or >80 years
- •Patients with significant valvular heart disease defined as symptomatic aortic valve disease, severe aortic or mitral stenosis or tricuspid or mitral insufficiency grade 3/4 or 4/4
- •Patients with pulmonary arterial hypertension >45 mmHg on echocardiography
- •Patients with chronic respiratory disease, chronic obstructive pulmonary disease stage II, III or IV.
- •Patients with a left ventricular ejection fraction <45%
- •Patients with recent (<1 month) acute decompensation of heart failure
- •Patients with recent (<1 month) acute coronary syndrome
- •Anemia (hemoglobin <10 g/dL)
- •Pregnant or lactating women
- •Patients with anticipated poor compliance, as assessed by the study investigator
- •Patients within the exclusion period of another clinical study
- •Patients under legal guardianship
研究组 & 干预措施
Cardioversion group
Patients with persistent atrial fibrillation who are oriented for cardioversion in the course of routine care.
干预措施: Cardioversion (Procedure)
Ablation group
Patients with persistent or paroxystic atrial fibrillation who are oriented for ablation of AF in the course of routine care.
干预措施: Ablation of atrial fibrillation (Procedure)
结局指标
主要结局
Recurrent atrial fibrillation
时间窗: 12 months
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Recurrent flutter
时间窗: 12 months
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
Recurrent atrial tachycardia
时间窗: 12 months
Documented by ECG, Holter, telemetry, and lasting 30 seconds or more.
次要结局
- Palpitations(12 months)
- Hospitalization(12 months)
- Recurrent flutter(3 months)
- Recurrent atrial fibrillation(3 months)
- Recurrent atrial tachycardia(3 months)
- Repeat ablation(12 months)
- Cardioversion(12 months)