CAtheter-Based Ablation of atrial fibrillation compared to conventional treatment in patients with Heart Failure with Preserved Ejection Fraction - Investigator-initiated, prospective, parallel-group, randomized, open, blinded endpoint assessment (PROBE), interventional multicenter strategy trial

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. Age >=18 years
2. Signed written informed consent
3. Clinical evidence of symptomatic heart failure (NYHA class II-III)
4. Paroxysmal or persistent atrial fibrillation (less than 24 months after
first diagnosis, documented at
least on one 12-lead ECG)
5. 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):
a. Left atrial (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
b. Left ventricular hypertrophy (septal thickness or posterior wall thickness
>=1.1cm or relative
wall thickness >0.42)
6. Patients with at least 1 of the following:
a. HF hospitalization (defined as HF listed as the major reason for
hospitalization) within 6
months prior to the 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
b. NT-proBNP >300 pg/ml for patients in SR or >900 pg/ml for patients in AF on
screening ECG

Exclusion Criteria

1. Patient is unable or unwilling to provide informed consent
2. Patient is not suitable for rhythm control of AF
3. Previous left atrial CA or surgical therapy of AF
4. Acutely decompensated HF, NYHA IV (patients can be enrolled after
stabilization)
5. Valvular heart disease needing interventional or surgical treatment within 3
months
6. Heart surgery planned within 3 months
7. Prior heart transplant or listed for heart transplant or cardiac assist
device implantation
8. Untreated hypothyroidism or hyperthyroidism (after successful treatment of
thyroid dysfunction,
patients may be enrolled)
9. Patient has contra-indication to oral anticoagulation
10. Any disease that limits life expectancy to less than 1 year
11. Active systemic infection (after successful treatment of infection,
patients may be enrolled)
12. Women currently pregnant or breastfeeding or women of childbearing
potential without highly
effective contraception (PEARL-Index < 1%),
13. Patient is included in another clinical trial
14. Inability to comply with the study procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is defined as a composite of cardiovascular death, stroke,<br /><br>and total (first and recurrent) unplanned cardiovascular hospitalization for<br /><br>heart failure or acute coronary syndrome. </p><br>

Secondary Outcome Measures