NCT06578793

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Persistent atrial fibrillation (AF) combined with heart failure presents a significant clinical challenge due to the high rates of morbidity and mortality associated with these conditions. Catheter ablation is widely used to manage AF, but its efficacy in persistent AF, particularly in patients with heart failure, is limited. Recent advances suggest that targeting the Marshall vein with ethanol ablation may offer additional benefits by disrupting critical pathways involved in AF maintenance. This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population. Conducted across three centers, this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes, including lower AF recurrence rates and improved heart function. The study's findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group.

Conditions

• Atrial Fibrillation, Persistent
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Catheter 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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-31
• Completion: 2026-01-31
• First posted: 2024-08-29
• Last updated: 2024-08-29

Locations

1 site across 1 country: China