CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction

HFpEF accounts for approximately half of HF diagnoses and HFmrEF adds another 20%. HFpEF patients are predisposed to AF with a prevalence of AF up to 65%. Conversely, the presence of AF increases the likelihood of subsequent HFpEF by up to 4-fold across diverse populations. The vulnerable hemodynamic state in HFpEF patients due to LV diastolic dysfunction can be significantly affected by AF with loss of atrial contraction and reduction in cardiac output. Thus, presence of AF in HFpEF patients leads to a significant increase in hospitalization, mortality and stroke.

Restoring and maintaining sinus rhythm in patients with HFpEF and AF could reduce cardiovascular (CV) outcomes. Catheter ablation (CA), particularly when performed as initial rhythm control, results in less recurrences of AF than anti arrhythmic drug therapy. In patients with HF with reduced ejection fraction (HFrEF) and AF, CA showed a significant reduction in all-cause mortality and worsening HF admissions compared to medical therapy.

No randomized clinical trial has tested or is currently testing the effects of CA on CV outcomes in patients with HFmrEF or HFpEF and AF. To address this, CABA-HFPEF tests whether CA can improve CV outcomes compared to usual care in these patients. The results of CABA-HFPEF will critically extend the current evidence on ablation-based rhythm control to this large population in dire need for treatments that improve clinical outcomes.

• All-cause mortality [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Cardiovascular death [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Stroke [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Unplanned hospitalization for atrial arrhythmia [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Total (first and recurrent) planned and unplanned cardiovascular hospitalizations [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Nights spent in hospital [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Days alive and out of hospital [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Atrial fibrillation burden (percentage of AF at 12 months FU Holter ECG) [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Change in left ventricular ejection fraction at 12 months FU [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Change in NYHA class at 12 months FU [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]
• Change in EHRA score at 12 months FU [Срок оценки: The secondary endpoints will be documented for at least 12 months following randomization. Estimated first patient in to last patient out 48 months]