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

Plain Language Summary

Simplified for easier understanding

This trial is studying whether catheter-based ablation (a procedure to reset heart rhythm) works better than standard medications for people who have both atrial fibrillation (AFib) and heart failure with preserved or mildly reduced ejection fraction. **You may be eligible if...** - You are 18 or older with symptomatic heart failure (NYHA class II or III) - You have paroxysmal or persistent AFib diagnosed within the last 24 months, confirmed on an ECG - Your heart's pumping function is between 40–49%, or 50%+ with certain heart structural changes on echo - You have had a recent heart failure hospitalization or elevated BNP/NT-proBNP levels **You may NOT be eligible if...** - You have already had a catheter ablation or surgical procedure for AFib - You have severe decompensated heart failure (NYHA class IV) - You have significant valve disease requiring intervention - You are unwilling or unable to give informed consent or follow the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.