EXCLAMATORY: EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation TO Reduce Atrial Fibrillation Burden and Correlation With Exercise CapacitY Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.
研究概览
简要总结
Longitudinal, observational cohort study to evaluate changes in left atrial (LA) reservoir function during exercise and overall exertional capacity in patients following catheter ablation for paroxysmal atrial fibrillation (AF).
详细描述
EXCLAMATORY is a longitudinal observational cohort clinical research study to evaluate the effects of catheter ablation for paroxysmal atrial fibrillation on left atrial and left ventricular performance during exercise, as well as effects on overall exercise capacity
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
- •Age ≥18 years
- •Diagnosis of paroxysmal AF
- •Left ventricular ejection fraction ≥50%
- •Scheduled for catheter ablation
- •Able to speak, hear, and read English
- •Willing and able to provide informed consent
排除标准
- •Persistent or permanent AF
- •Prior ablation (catheter based or surgical) for AF
- •Significant sinus node dysfunction
- •Implanted pacemaker or defibrillator
- •Contraindication to or inability to complete cardiovascular magnetic resonance study
- •Contraindication to or inability to complete exercise testing
- •Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73m2
- •Severe left ventricular hypertrophy
- •Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:
- •Hypertrophic cardiomyopathy
- •Cardiac amyloidosis
- •Constrictive pericarditis
- •Pulmonary arterial hypertension
- •Prior cardiac surgery
- •Active pregnancy
研究组 & 干预措施
Patients under going catheter ablation
Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
干预措施: Self- Report Evaluation-Duke Activity Status Index (Behavioral)
Patients under going catheter ablation
Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
干预措施: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire (Behavioral)
Patients under going catheter ablation
Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
干预措施: Cardiopulmonary exercise test (CPET) (Diagnostic Test)
Patients under going catheter ablation
Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
干预措施: Transthoracic echocardiogram (Diagnostic Test)
Patients under going catheter ablation
Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
干预措施: Ambulatory cardiac rhythm assessment (Diagnostic Test)
Patients under going catheter ablation
Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
干预措施: Cardiovascular magnetic resonance (CMR) (Diagnostic Test)
结局指标
主要结局
Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.
时间窗: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Change in LA reservoir volume reserve from baseline to follow up, change in left ventricular (LV) stroke volume reserve from baseline to follow up, correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve. Therefore the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
次要结局
- Correlation between changes in LA reservoir volume reserve and changes in LV stroke vol reserve after catheter ablation in patients with paroxysmal AF(Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.)
- Correlation between baseline AF burden and LA function, LV Function and pVO2(Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.)
- Change in LV stroke volume reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.(Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.)
- Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in mixed venous oxygen tension (pVO2) .(Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.)
- Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2(Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.)
- Correlation between the amount of AF burden reduction and the changes in LA function, LV function (rest and exercise), and pVO2.(Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.)