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.
Age between 18 and 80 years
For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration exceeding 7 days without spontaneous conversion to sinus rhythm; at least two episodes of persistent atrial fibrillation in the past 6 months even after rhythm conversion; poor tolerance or resistance to at least one Class I, II, or III antiarrhythmic drug
Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
Patient willing to receive medication or surgical treatment
Presence of thrombus in the left atrium
Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by MRI or CT
Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
Parallel
Catheter Ablation Combined with Marshall Vein Ethanol Ablation
Procedure/SurgeryThis 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.
Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence
The primary outcome is the proportion of participants who remain free from clinical recurrence of atrial fibrillation (AF) or atrial flutter (AFL) at follow-up. Recurrence is defined as the absence of documented AF/AFL episodes lasting 30 seconds or more during continuous ECG monitoring over a 1-month period.
Change in NT-proBNP Levels
This outcome measures the change in NT-proBNP levels, a biomarker for heart failure, from baseline to follow-up, indicating the impact of the intervention on heart failure status.
Change in Left Ventricular Ejection Fraction (LVEF)
This outcome assesses the change in LVEF as measured by echocardiography, reflecting the effect of the intervention on cardiac function.
Change in 6-Minute Walk Test Distance
This outcome measures the change in the distance covered during the 6-minute walk test, an indicator of functional capacity and exercise tolerance.
Presence or Absence of Arrhythmias Within 30 Days
This outcome measures whether arrhythmias related to the procedure occurred within 30 days post-intervention.
Presence or Absence of Chest Tightness Within 30 Days
This outcome measures whether chest tightness related to the procedure occurred within 30 days post-intervention.
Presence or Absence of Palpitations Within 30 Days
This outcome measures whether palpitations related to the procedure occurred within 30 days post-intervention.
Presence or Absence of Bleeding Within 30 Days
This outcome measures whether bleeding related to the procedure occurred within 30 days post-intervention.
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