Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

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.

• ACMP progression or regression [Срок оценки: through study completion, a median of 2.5 years]
• Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT) [Срок оценки: through study completion, a median of 2.5 years]
• Hospitalisations/urgent visits for heart failure (HF) [Срок оценки: through study completion, a median of 2.5 years]
• Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA)) [Срок оценки: through study completion, a median of 2.5 years]
• Cardiovascular death [Срок оценки: through study completion, a median of 2.5 years]
• All-cause mortality [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: through study completion, a median of 2.5 years]