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

Recruiting now · Phase 4

Conditions studied: Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction

In brief

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).

Key facts

Study ID

NCT05508256

Run by

Charite University, Berlin, Germany

People needed

1548

Starts

2023-03-01

Expected to finish

2027-07-01

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• 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)
• 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

You may not qualify if…

• Patient is unable or unwilling to provide infomed consent
• Patient is not suitable for rhythm control of AF
• Previous left atrial CA or surgical therapy of AF
• Acutely decompensated HF, NYHA IV (patients can be enrolled after stabilization)
• Valvular heart disease needing interventional or surgical treatment within 3 months
• Heart surgery planned within 3 months
• Prior heart transplant or listed for heart transplant or cardiac assist device implantation
• Untreated hypothyroidism or hyperthyroidism (after successful treatment of thyroid dysfunction, patients may be enrolled)
• Patient has absolute contra-indication to oral anticoagulation
• Any disease that limits life expectancy to less than 1 year
• Active systemic infection (after successful treatment of infection, patients may be enrolled)
• 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

Where it is running

• Charité University Medicine Berlin, Campus Virchow Klinikum — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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