CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Aug 17, 2022
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called CABA-HFPEF, is investigating whether a procedure known as catheter ablation can help patients with atrial fibrillation (AF) and heart failure (HF) prevent serious heart problems. The trial is focused on people who have heart failure with either preserved or mildly reduced heart function, which means their heart is still pumping well enough but may not be functioning at its best. Researchers want to see if this ablation procedure, which uses heat or cold to target and destroy small areas of heart tissue causing irregular heartbeats, can improve outcomes for these patients compared to standard treatments.
To participate in the trial, individuals must be at least 18 years old and have symptoms of heart failure, such as shortness of breath or fatigue. They should have been diagnosed with AF within the last two years and have specific heart function measurements. Participants will undergo a thorough screening process to ensure they qualify. If eligible, they can expect to receive either the catheter ablation procedure or conventional treatment and will be closely monitored throughout the study to assess their health outcomes. This trial is a promising opportunity for individuals seeking new ways to manage their heart conditions.
Gender
ALL
Eligibility criteria
- 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
About Charite University, Berlin, Germany
Charité - Universitätsmedizin Berlin is a leading academic medical center in Germany, renowned for its commitment to excellence in research, education, and patient care. As one of Europe's largest university hospitals, Charité integrates cutting-edge clinical practices with innovative research initiatives, fostering interdisciplinary collaboration across various medical fields. The institution is dedicated to advancing healthcare through rigorous clinical trials, contributing to the development of new therapies and treatment protocols. With a strong emphasis on translational medicine, Charité aims to bridge the gap between scientific discovery and practical application, ultimately enhancing patient outcomes and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Berlin, , Germany
Patients applied
Trial Officials
Abdul Parwani, Dr.
Principal Investigator
Head of Electrophysiology; Charité University Medicine Berlin, CVK
Paulus Kirchhof, Prof. Dr.
Study Chair
Director Department of Cardiology, Heart and Vascular Center University Hamburg Eppendorf
Stefan Kääb, Prof. Dr.
Study Chair
Department of Cardiology, Ludwig-Maximilians-University Hospital Munich
Tim Friede, Prof. Dr.
Study Chair
Departement of Medical Statistics, University Medical Center Göttingen
Roland Tilz, Prof. Dr.
Study Chair
Head of Electrophysiology Department, University Hospital Lübeck
Burkert Pieske, Prof. Dr.
Study Chair
Independent
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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