RecruitingPhase 4NCT05508256

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

Sponsor

Charite University, Berlin, Germany

Enrollment

1,548 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Heart Failure With Preserved Ejection Fraction Heart Failure With Mildly Reduced Ejection Fraction

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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

Exclusion Criteria14

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

Interventions

DEVICECE-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.