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Search / Trial NCT05508256

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

Atrial Fibrillation Heart Failure Catheter Ablation Medial Therapy

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.

Locations

Berlin, , Germany

Patients applied

0 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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