Ablation Versus Medical Management of Atrial Fibrillation in HFpEF
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- STATUS
- Recruiting
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- End date
- Jan 29, 2025
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- participants needed
- 60
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- sponsor
- Johns Hopkins University
Summary
This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
Description
Recent studies using PVI for rhythm control in patients with heart failure with reduced ejection fraction (HFrEF) have shown improvement in systolic ejection fraction, exercise capacity, quality of life, and a significant reduction in all-cause mortality. The PVI procedure has been shown to be safe and comparably effective in treating Atrial Fibrillation (AF) in HFpEF patients, but no studies have yet demonstrated the effects of catheter ablation on exercise capacity or clinical outcomes.
The investigators propose a prospective, non-blinded randomized control pilot study to assess the feasibility of conducting larger scale studies to determine if there are differences between catheter ablation with medical management on exercise capacity and quality of life in HFpEF patients with AF. The investigators' study will be powered for AF burden reduction, and the investigators hope to use the effect size on exercise capacity and heart failure events to help determine power for larger clinical studies that will follow to shed light on how invasive management of atrial fibrillation may impact the natural history of individuals with these two cardiovascular conditions.
Details
| Condition | Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Heart Failure With Normal Ejection Fraction |
|---|---|
| Age | 18-90 years |
| Treatment | Pulmonary Vein Isolation |
| Clinical Study Identifier | NCT04282850 |
| Sponsor | Johns Hopkins University |
| Last Modified on | 19 February 2024 |
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