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Clinical Trials in Germany / NCT05508256
Recruiting Phase 4

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

NCT05508256 · tracked via the Priya Life Science Germany tracker
Phase
Phase 4
Started
2023-03
Last updated
2023-03-06

Condition(s) studied

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)

Trial sites (1)

FacilityCityRegionStatus
Charité University Medicine Berlin, Campus Virchow Klinikum Berlin Germany Recruiting

More Charite University, Berlin, Germany trials in Germany

Other trials for the same condition

Official registry record

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.

View NCT05508256 on ClinicalTrials.gov ↗ ← All trials in Germany