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

Second Xiangya Hospital of Central South University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Interventions

Catheter Ablation Combined with Marshall Vein Ethanol AblationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 80 years 2. 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 3. Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40% 4. Patient willing to receive medication or surgical treatment 5. Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form 6. Capable of completing a 6-minute walk test 7. For women of childbearing potential, a negative pregnancy test result is required Exclusion Criteria: 1. Presence of thrombus in the left atrium 2. 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 3. Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study 4. Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma 5. Currently suffering from valvular heart disease requiring surgical intervention 6. Currently suffering from coronary artery disease requiring surgical or percutaneous intervention 7. History of atrioventricular node ablation 8. Liver failure 9. Renal failure requiring dialysis 10. Contraindicated use of appropriate anticoagulation therapy 11. Participation in other experimental drug or device studies 12. Severe pulmonary disease 13. Previous catheter ablation for atrial fibrillation in the left atrium 14. Documented thromboembolic event within the past 90 days 15. Pregnant women

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months after the procedure

Secondary Outcomes

Presence or Absence of Arrhythmias Within 30 Days

This outcome measures whether arrhythmias related to the procedure occurred within 30 days post-intervention.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months after the procedure

Total Number of Procedures Performed

This outcome measures the total number of procedures performed during the intervention.

Time frame: During the procedure(s)

Total Radiofrequency Ablation Time for the First Procedure

This outcome measures the total radiofrequency ablation time during the first procedure.

Time frame: 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.

Time frame: 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).

Time frame: During the procedure(s)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts