Catheter Ablation for Atrial Fibrillation in People With Heart Failure
Tests catheter ablation for atrial fibrillation in adults with heart failure and preserved ejection.
Plain-language title generated from the registry record
Registry title: CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
Key facts
- Where
- Berlin, GermanySee the site
- Phase
- Phase 4
Where in Germany
- Charité University Medicine Berlin, Campus Virchow KlinikumBerlin, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charite University, Berlin, Germany
- Trial code
- NCT05508256
- Record updated
- 6 March 2023
- Original description
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).Read full original descriptionShow less
CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With Heart Failure With Preserved Ejection Fraction
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).
Inclusion: Age ≥18 years; Signed written informed consent; Clinical evidence of symptomatic heart failure (NYHA Class II-III); Paroxysmal or persistent atrial fibrillation (less than 24 months after first diagnosis, documented at least on one 12-lead ECG); 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):; 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; Left ventricular hypertrophy (septal thickness or posterior wall thickness ≥1.1 cm or relative wall thickness >0.42); Patients with at least 1 of the following:; 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; NT-proBNP >300 pg/ml for patients in SR or >900 pg/ml for patients in AF on screening ECG.
Exclusion: Previous left atrial CA or surgical therapy of AF; Prior heart transplant or listed for heart transplant or cardiac assist device implantation; Valvular heart disease needing interventional or surgical treatment within 3 months; Heart surgery planned within 3 months; Any disease that limits life expectancy to less than 1 year; Active systemic infection (after successful treatment of infection, patients may be enrolled); Patient is unable or unwilling to provide infomed consent; Patient is not suitable for rhythm control of AF; Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization); Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled); Patient has absolute contra-indication to oral anticoagulation; Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index < 1%); Patient is included in another clinical trial; Inability to comply with the study procedures.