RecruitingNot ApplicableNCT06578793

Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure

Comparison of Catheter Ablation Combined With Ethanol Ablation of the Marshall Vein vs. Catheter Ablation Alone in Persistent Atrial Fibrillation With Heart Failure: A Multicenter Randomized Controlled Study

Sponsor

Second Xiangya Hospital of Central South University

Enrollment

120 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation, Persistent

Summary

This multicenter, randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation (AF) and concomitant heart failure. Persistent AF is a common arrhythmia that significantly impacts the quality of life and survival rates, especially when coexisting with heart failure. While catheter ablation is a standard treatment for AF, its effectiveness in persistent AF, particularly in patients with heart failure, remains suboptimal. The addition of Marshall vein ethanol ablation may enhance treatment outcomes by targeting arrhythmogenic substrates. This study will enroll 120 participants across three centers to evaluate whether this combined approach can reduce AF recurrence, improve heart function, and enhance patient outcomes compared to catheter ablation alone.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding Marshall vein ablation (ablating an additional heart structure) to standard catheter ablation improves outcomes in people who have both persistent atrial fibrillation (a persistent irregular heartbeat) and heart failure. **You may be eligible if...** - You are between 18 and 80 years old - You have persistent atrial fibrillation that has lasted at least 6 months or has recurred despite treatment - You have heart failure with reduced pumping function (ejection fraction ≤ 45%) - Standard antiarrhythmic medications have been ineffective or poorly tolerated **You may NOT be eligible if...** - You have a blood clot in the heart - You have severe valve disease or other structural heart conditions - You have had a recent stroke or heart attack (within 3 months) - You are pregnant 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

PROCEDURECatheter Ablation Combined with Marshall Vein Ethanol Ablation

This study involves two procedures. The first procedure is a combination of catheter ablation with ethanol ablation of the Marshall vein. The second procedure is catheter ablation alone. Both procedures involve standard techniques used to treat persistent atrial fibrillation, with the addition of Marshall vein ethanol ablation in the experimental group aimed at potentially improving outcomes by targeting additional arrhythmogenic substrates.

Locations(1)

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT06578793

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