Actively Recruiting
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
Led by Second Xiangya Hospital of Central South University · Updated on 2024-08-29
120
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness and safety of catheter ablation combined with Marshall vein ethanol ablation against catheter ablation alone in patients with persistent atrial fibrillation (AF) and heart failure. Persistent AF significantly affects quality of life and survival, especially when combined with heart failure. This multicenter, randomized controlled trial involves 120 participants to determine if the combined approach reduces AF recurrence and improves heart function and patient outcomes compared to standard catheter ablation. Participants will be assigned to one of two groups: one receiving standard catheter ablation with pulmonary vein isolation and possibly additional atrial ablation guided by imaging, plus Marshall vein ethanol ablation where ethanol is injected into the Marshall vein to target arrhythmogenic tissue; the other group will receive standard catheter ablation alone. The procedures use fluoroscopy and 3D electroanatomical mapping for precision. The study aims to evaluate whether the combined treatment offers better clinical results for this challenging patient population. During the study, participants will be monitored for 12 months after the procedure with assessments including freedom from AF or atrial flutter recurrence, changes in heart function measured by NT-proBNP levels and left ventricular ejection fraction, exercise capacity via a 6-minute walk test, and heart failure severity by NYHA functional class. Additional evaluations include arrhythmia presence, symptoms, bleeding, mortality, and detailed measures of ablation procedure characteristics. Follow-up will involve clinical visits and tests to assess safety and treatment effects over time.
CONDITIONS
Brief Title
Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Symptomatic persistent atrial fibrillation with at least 6 months history
- Atrial fibrillation lasting more than 7 days without spontaneous conversion to normal rhythm
- At least two episodes of persistent atrial fibrillation in past 6 months despite rhythm conversion
- Poor tolerance or resistance to at least one Class I, II, or III antiarrhythmic drug
- Diagnosed heart failure with left ventricular ejection fraction (LVEF) of 40% or less
- Willingness to receive medication or surgical treatment
- Ability to comply with study requirements and provide informed consent
- Ability to complete a 6-minute walk test
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Presence of blood clot in the left atrium
- Left atrial diameter greater than 65 mm or volume over 200 ml by MRI or CT
- Significant congenital abnormalities or other medical issues unsuitable for study
- Reversible causes of atrial fibrillation such as pericarditis, thyroid disease, recent surgery, trauma, or alcohol intoxication
- Valvular heart disease needing surgery
- Coronary artery disease requiring surgical or percutaneous intervention
- History of atrioventricular node ablation
- Liver failure
- Kidney failure requiring dialysis
- Contraindications to anticoagulation therapy
- Participation in other experimental drug or device studies
- Severe lung disease
- Previous catheter ablation for atrial fibrillation in left atrium
- Thromboembolic event within past 90 days
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with hospital stay as needed
Participants undergo catheter ablation procedures to treat persistent atrial fibrillation. One group receives standard catheter ablation combined with ethanol ablation of the Marshall vein, while the other group receives catheter ablation alone.
1 procedure visit (in-person) followed by close monitoring during hospital stay
Duration - 12 months
Participants are monitored for atrial fibrillation recurrence, heart function, and symptoms for up to 12 months after the procedure.
Regular follow-up visits including assessments at 1 month, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
L
Li Xuping
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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