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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence [Срок оценки: 12 months after the procedure]
• Change in NT-proBNP Levels [Срок оценки: 12 months after the procedure]
• Change in Left Ventricular Ejection Fraction (LVEF) [Срок оценки: 12 months after the procedure]
• Change in 6-Minute Walk Test Distance [Срок оценки: 12 months after the procedure]
• Change in NYHA Functional Class [Срок оценки: 12 months after the procedure]

Вторичные конечные точки (11)

• Presence or Absence of Arrhythmias Within 30 Days [Срок оценки: 30 days after the procedure]
• Presence or Absence of Chest Tightness Within 30 Days [Срок оценки: 30 days after the procedure]
• Presence or Absence of Palpitations Within 30 Days [Срок оценки: 30 days after the procedure]
• Presence or Absence of Bleeding Within 30 Days [Срок оценки: 30 days after the procedure]
• Presence or Absence of Mortality Within 30 Days [Срок оценки: 30 days after the procedure]
• Atrial Fibrillation Burden at 6 Months [Срок оценки: 6 months after the procedure]
• Atrial Fibrillation Burden at 12 Months [Срок оценки: 12 months after the procedure]
• Total Number of Procedures Performed [Срок оценки: During the procedure(s)]
• Total Radiofrequency Ablation Time for the First Procedure [Срок оценки: During the first procedure]
• Total Radiofrequency Ablation Time for the Second Procedure (if applicable) [Срок оценки: During the second procedure]
• Total Area of Left Atrial (LA) Tissue Ablated [Срок оценки: During the procedure(s)]

Критерии участия

Критерии включения

• 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
• Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
• Capable of completing a 6-minute walk test
• For women of childbearing potential, a negative pregnancy test result is required

Критерии исключения

• 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
• Currently suffering from valvular heart disease requiring surgical intervention
• Currently suffering from coronary artery disease requiring surgical or percutaneous intervention
• History of atrioventricular node ablation
• Liver failure
• Renal failure requiring dialysis
• Contraindicated use of appropriate anticoagulation therapy
• Participation in other experimental drug or device studies
• Severe pulmonary disease
• Previous catheter ablation for atrial fibrillation in the left atrium
• Documented thromboembolic event within the past 90 days
• Pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Second Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT06578793 · XYSY_CAB_MVA_2024_001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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