Eligibility criteria+98 characters
InclusionINCLUSION CriteriaCRITERIA:
Age ≥18 years
Signed written informed consent
Clinical evi [...] II)
Paroxysmal or persistent atrial fibrillation (less than 1224 months andafter notfirst longer than 24 monthsdiagnosis, documented at least on one 12-lead ECG)
Left ventricular e [...] gs (any local measurement made during the screening epoch):
A. LA enlargement defined by at least 1 of the following: LA wi [...] ea ≥20 cm2 or LA volume ≥55 ml or LA volume index ≥29 ml/m2
B. Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1cm1 cm or relative wall thickness >0.42)
Patients with at le [...] [...]
Secondary endpoints12 to 13 entries
Stroke
Total (first and recurrent) unplanned cardiovascular hospitalization (HF,for heart failure or acute coronary syndrome, or stroke)
Number of nightsNights spent in hospital
Number of daysDays alive and out of hospital
AFAtrial fibrillation burden (percentage of AF at 12 months FU Holter ECG)
Percentage changeChange in left ventricular ejection fraction at 12 months FU
Change in NYHA class (I-IV) at 12 months FU
Change in EHRA score (I-IV) at 12 months FU
Change in quality of life at 12 months FU (measured by KCCQ score)
Primary endpoints1 entry, revised
The primary outcome is defined as survival time free of thea composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization (Heartfor heart failure, or acute coronary syndrome or stroke).
Study sitesdetails revised at 1 of 1 site
Study title+8 characters
CAtheter-Based Ablation of Atrial Fibrillation vs.Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction