Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Catheter Ablation Combined with Marshall Vein Ethanol Ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Persistent, Heart Failure. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
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.
Interventions
- 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.
Primary outcome measures
- Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence [Time frame: 12 months after the procedure]
- Change in NT-proBNP Levels [Time frame: 12 months after the procedure]
- Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: 12 months after the procedure]
- Change in 6-Minute Walk Test Distance [Time frame: 12 months after the procedure]
- Change in NYHA Functional Class [Time frame: 12 months after the procedure]
Secondary outcome measures (11)
- Presence or Absence of Arrhythmias Within 30 Days [Time frame: 30 days after the procedure]
- Presence or Absence of Chest Tightness Within 30 Days [Time frame: 30 days after the procedure]
- Presence or Absence of Palpitations Within 30 Days [Time frame: 30 days after the procedure]
- Presence or Absence of Bleeding Within 30 Days [Time frame: 30 days after the procedure]
- Presence or Absence of Mortality Within 30 Days [Time frame: 30 days after the procedure]
- Atrial Fibrillation Burden at 6 Months [Time frame: 6 months after the procedure]
- Atrial Fibrillation Burden at 12 Months [Time frame: 12 months after the procedure]
- Total Number of Procedures Performed [Time frame: During the procedure(s)]
- Total Radiofrequency Ablation Time for the First Procedure [Time frame: During the first procedure]
- Total Radiofrequency Ablation Time for the Second Procedure (if applicable) [Time frame: During the second procedure]
- Total Area of Left Atrial (LA) Tissue Ablated [Time frame: During the procedure(s)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Second Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT06578793 · XYSY_CAB_MVA_2024_001