PRospective Cohort Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Valve Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Atrial fibrillation detection
研究概览
简要总结
The PRIME-LOOP study is a prospective cohort investigating the burden of atrial fibrillation (AF) and subclinical AF in patients with moderate-severe or severe primary mitral regurgitation (MR). The study will use long-term cardiac monitoring with an implantable loop recorder (ILR) for up to three years to identify the burden of AF. Further, the study aims to examine the associated risk of adverse events among patients with detected AF as compared with patients without AF. Only patients with no or mild symptoms related to MR and without a class I indication for surgical intervention will be included. The study aims to include 100 patients.
Patients will be screened from the PRIME cohort - a prospective cohort of patients with primary MR in East Denmark.
详细描述
Purpose
There are two main purposes of this study: 1) to assess atrial fibrillation (AF) burden in patients with asymptomatic severe primary degenerative mitral regurgitation (MR) but no known AF using the CE marked Reveal LINQ™ Insertable Cardiac Monitor (ICM), and 2) to examine the association between subclinical AF and deterioration of left ventricular (LV) dysfunction, progression of symptoms, and time to surgery.
We hypothesize that:
- Within one year of follow-up, up to 30% of patients with significant, asymptomatic, primary MR will have previously unknown AF detected when evaluated by continuous monitoring.
- The deterioration of LV dysfunction, progression of symptoms, and time to surgery are aggravated by subclinical AF.
Background
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
- •Asymptomatic/mildly symptomatic*, significant primary MR**
- •LVEF ≥60%
- •Native mitral valve
- •Age ≥18 years old
排除标准
- •Prior diagnosis of AF
- •Prescence of cardiac pacemaker, ICD, cardiac resynchronization device, loop recorder, or a clinical indication for loop recorder
- •LVESD ≥ 40 mm
- •Planned for mitral valve surgery
- •Life expectancy < 1 year
- •Pregnancy or lactating
研究组 & 干预措施
Patients with ILR
结局指标
主要结局
Atrial fibrillation detection
时间窗: 3 years
Episode of ≥6 minutes of consecutive AF at any time during the 3-year monitoring time
次要结局
- Atrial fibrillation detection(3 years)
- Supraventricular tachycardia(3 years)
- Sinus arrest/asystole(3 years)
- Atrioventricular block(3 years)
- Sustained ventricular tachycardia(3 years)
- Nonsustained ventricular tachycardia(3 years)
- Ventricular fibrillation(3 years)
- AF burden(3 years)
- AF progression(3 years)
- Increase in NT-proBNP(3 years)
- Increase in left ventricular end-systolic diameter (LVESD)(3 years)
- Increase in pulmonary artery systolic pressure (PASP)(3 years)
- Left atrial (LA) enlargement(3 years)
- Development of clinically diagnosed AF(3 years)
- Diagnosis of HF(3 years)
- Change in symptoms and quality of life(3 years)
- Initiation, discontinuation, or adjustment of antiarrhythmic medications(3 years)
- Initiation of anticoagulation therapy(3 years)
- Referral to or performance of cardiac surgery(3 years)
- Hospitalization ≥24 hours (all-cause and cardiovascular-specific)(3 years)
- Stroke or systemic embolism(3 years)
- Cardiovascular and all-cause mortality(3 years)
研究者
Lauge Østergaard
PRospective cohort study for the Identification of Subclinical atrial fibrillation In patients with significant primary Mitral valve regurgitation
Rigshospitalet, Denmark