Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.
研究概览
简要总结
The goal of clinical trial is to compare AF ablation to pharmacological rhythm management (being rate or rhythm control) in AF patients with signs of atrial cardiomyopathy (as defined by left atrial volume index >34 ml/m2) The main objective it aims to answer is to determine whether AF ablation compared to pharmacological rhythm management in ACMP patients with AF reduces the incidence of the composite primary endpoint of CV death and first CV hospitalization/urgent visit.
详细描述
The RACE X trial investigates the impact of atrial cardiomyopathy (ACMP) and ablation timing on adverse outcomes in atrial fibrillation (AF) patients. ACMP leads to an atrial substrate less responsive to rhythm control, exacerbating AF recurrence and progression. This trial assesses whether AF ablation versus pharmacological rhythm management reduces the combined primary endpoint of cardiovascular (CV) death and hospitalization in ACMP and AF patients. Secondary objectives include measuring ACMP progression, ACMP-related outcomes, mortality, hospitalizations, AF symptoms, quality of life, and healthcare costs. Exploratory goals involve various additional measurements. This prospective, multicenter, open-label, blinded-endpoint, phase IIIb trial randomizes patients with ACMP and AF to receive either AF ablation or pharmacological rhythm management. Follow-up involves mobile health (mHealth) applications, questionnaires, and heart rhythm monitoring across 13 Dutch hospitals. Ineligible patients undergoing AF ablation join an observational registry. The trial population consists of patients aged 65-80 years with confirmed ACMP and ECG-confirmed AF. With 604 patients and a median 2.5-year follow-up, the trial aims to assign patients equally to each intervention. The primary endpoint is a composite of CV death and hospitalization. Catheter ablation, a safe and efficient technique, minimizes patient burden, and remote follow-up through mHealth reduces site visits. Additional study procedures are integrated into routine care, ensuring a streamlined process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
endpoints will be adjudicated by a blinded clinical endpoint committee
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AF ablation
These patients will undergo Pulmonary vein isolation (PVI) (only)
干预措施: Pulmonary vein isolation (Procedure)
Pharmacological rhythm management
These patients will take rate control medication. If this therapy fails, pharmacological rhythm control and AF ablation are 2nd and 3rd line options respectively within this arm,
干预措施: Pharmacological rhythm management (Drug)
结局指标
主要结局
A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.
时间窗: through study completion, a median of 2.5 years
Atrial cardiomyopathy (ACMP)-associated complications
次要结局
- ACMP progression or regression(through study completion, a median of 2.5 years)
- Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)(through study completion, a median of 2.5 years)
- Hospitalisations/urgent visits for heart failure (HF)(through study completion, a median of 2.5 years)
- Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))(through study completion, a median of 2.5 years)
- Cardiovascular death(through study completion, a median of 2.5 years)
- All-cause mortality(through study completion, a median of 2.5 years)
- Symptoms and improve quality of life (QoL) measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL)(through study completion, a median of 2.5 years)
- Symptoms and improve quality of life (QoL) measured by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire (higher score indicating less symptoms and a better QoL)(through study completion, a median of 2.5 years)