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

Korábbi kezelés

• Previous left atrial CA or surgical therapy of AF
• Prior heart transplant or listed for heart transplant or cardiac assist device implantation

Más betegség

• Valvular heart disease needing interventional or surgical treatment within 3 months
• Heart surgery planned within 3 months
• Any disease that limits life expectancy to less than 1 year
• Active systemic infection (after successful treatment of infection, patients may be enrolled)

Egyéb

• Patient is unable or unwilling to provide infomed consent
• Patient is not suitable for rhythm control of AF
• Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
• Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled)
• Patient has absolute contra-indication to oral anticoagulation
• Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index < 1%)
• Patient is included in another clinical trial
• Inability to comply with the study procedures

• Age ≥18 years
• Signed written informed consent
• Clinical evidence of symptomatic heart failure (NYHA Class II-III)
• Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG)
• Left ventricular ejection fraction (LVEF) 40-49%
  • OR
  • LVEF ≥ 50% with at least one of the following HFpEF echocardiography findings (any local measurement made during the screening epoch):
  • LA enlargement defined by at least 1 of the following: LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml/m2
  • Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1 cm or relative wall thickness >0.42)
• Patients with at least 1 of the following:
• HF hospitalization (defined as HF listed as the major reason for hospitalization) within 6 months prior to screening visit and NT-proBNP >200 pg/ml for patients in sinus rhythm (SR) or >600 pg/ml for patients in AF at the time of blood sampling
• NT-proBNP >300 pg/ml for patients in SR or >900 pg/ml for patients in AF on screening ECG