Catheter ablation for atrial fibrillation in heart failure patients

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

This study is testing if catheter ablation can help heart failure patients with atrial fibrillation avoid serious heart problems better than standard medication.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1548 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Charite University, Berlin, Germany (other)
• Locations: 1 site (Berlin)
• Trial ID: NCT05508256 on ClinicalTrials.gov

What this trial studies

The CABA-HFPEF trial aims to evaluate the effectiveness of catheter ablation (CA) in preventing adverse cardiovascular outcomes in patients with heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF) who also have atrial fibrillation (AF). Given the high prevalence of AF in HFpEF patients and its detrimental effects on cardiac function, this study will compare CA to conventional medical therapy. The trial will include patients aged 18 and older with symptomatic heart failure and specific echocardiographic findings. By assessing the impact of CA on cardiovascular outcomes, the study seeks to provide critical insights into treatment options for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic heart failure and documented atrial fibrillation.

Not a fit: Patients with heart failure who do not have atrial fibrillation or those with advanced heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular outcomes and reduced hospitalizations for patients with heart failure and atrial fibrillation.

How similar studies have performed: While catheter ablation has shown success in patients with heart failure and reduced ejection fraction, this specific approach in HFpEF and HFmrEF patients is novel and has not been previously tested.

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

Where this trial is running

Berlin

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

Study contacts

• Principal investigator: Abdul Parwani, Dr. — Head of Electrophysiology; Charité University Medicine Berlin, CVK
• Study coordinator: Abdul Parwani, Dr.

Conditions: Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction, atrial fibrillation, heart failure, catheter ablation, medial therapy