Catheter ablation for atrial fibrillation in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: caba_hfpef@charite.de
• Phone: +4930450565383

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Maridebart cafraglutide for people with obesity and preserved or mildly reduced ejection fraction heart failure

  This trial will test whether adding maridebart cafraglutide to usual heart-failure care can reduce hospital visits, cardiovascular deaths, and improve symptoms in adults with obesity and HFpEF or HFmrEF.

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• Evaluating the effects of bariatric surgery on heart failure and atrial fibrillation

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• Using blood samples to identify heart failure risks in diabetes patients

  This study is trying to see if blood tests can help find out which people with type 2 diabetes are at risk for heart failure.

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• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

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• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.