Atrial FibrillationHeart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection Fraction
Investigational drug(s) / intervention(s)
CE-marked Catheter Ablation
CE-marked Catheter Ablation: Once patients have been randomized to the catheter ablation (CA) group, the ablation procedure must be performed within 4 weeks. CA will initially aim at pulmonary vein isolation.
Study summary
The objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. 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 ≥1.1 cm 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 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 infomed 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 absolute 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
Primary outcome measure(s)
The primary outcome is defined as a composite of cardiovascular death, stroke and total (first and recurrent) unplanned cardiovascular hospitalization for heart failure or acute coronary syndrome. — Estimated first patient in to last patient out 48 months.
Trial sites (1)
Facility
City
Region
Status
Charité University Medicine Berlin, Campus Virchow Klinikum
Berlin
Germany
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.