Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
NCT Number: NCT06578793
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation, Persistent|Heart Failure
Interventions: PROCEDURE: Catheter Ablation Combined with Marshall Vein Ethanol Ablation
Sponsor: Second Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2026-01-31
Locations: Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China

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.

Primary Outcome Measures: 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., 12 months after the procedure|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., 12 months after the procedure|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., 12 months after the procedure|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., 12 months after the procedure|Change in NYHA Functional Class, This outcome evaluates changes in the New York Heart Association (NYHA) functional classification, which assesses the severity of heart failure symptoms and functional limitations., 12 months after the procedure
Secondary Outcome Measures: Presence or Absence of Arrhythmias Within 30 Days, This outcome measures whether arrhythmias related to the procedure occurred within 30 days post-intervention., 30 days after the procedure|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., 30 days after the procedure|Presence or Absence of Palpitations Within 30 Days, This outcome measures whether palpitations related to the procedure occurred within 30 days post-intervention., 30 days after the procedure|Presence or Absence of Bleeding Within 30 Days, This outcome measures whether bleeding related to the procedure occurred within 30 days post-intervention., 30 days after the procedure|Presence or Absence of Mortality Within 30 Days, This outcome measures whether mortality related to the procedure occurred within 30 days post-intervention., 30 days after the procedure|Atrial Fibrillation Burden at 6 Months, This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 6 months post-intervention., 6 months after the procedure|Atrial Fibrillation Burden at 12 Months, This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 12 months post-intervention., 12 months after the procedure|Total Number of Procedures Performed, This outcome measures the total number of procedures performed during the intervention., During the procedure(s)|Total Radiofrequency Ablation Time for the First Procedure, This outcome measures the total radiofrequency ablation time during the first procedure., During the first procedure|Total Radiofrequency Ablation Time for the Second Procedure (if applicable), This outcome measures the total radiofrequency ablation time during the second procedure, if applicable., During the second procedure|Total Area of Left Atrial (LA) Tissue Ablated, This outcome measures the total area of left atrial (LA) tissue ablated during the procedure(s)., During the procedure(s)