CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
NCT05508256 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1548
Last updated 2023-03-06
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).
Conditions
- Atrial Fibrillation
- Heart Failure With Preserved Ejection Fraction
- Heart Failure With Mildly Reduced Ejection Fraction
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
collaborator OTHER -
Kompetenznetz Vorhofflimmern e.V. (AFNET)
collaborator UNKNOWN -
Boston Scientific Corporation
collaborator INDUSTRY -
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Abdul Parwani, Dr. · Head of Electrophysiology; Charité University Medicine Berlin, CVK
-
Paulus Kirchhof, Prof. Dr. · Director Department of Cardiology, Heart and Vascular Center University Hamburg Eppendorf
-
Stefan Kääb, Prof. Dr. · Department of Cardiology, Ludwig-Maximilians-University Hospital Munich
-
Tim Friede, Prof. Dr. · Departement of Medical Statistics, University Medical Center Göttingen
-
Roland Tilz, Prof. Dr. · Head of Electrophysiology Department, University Hospital Lübeck
-
Burkert Pieske, Prof. Dr. · Independent
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2026-07-31
- Completion
- 2027-07-31
Countries
- Germany
Study Locations
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