Actively Recruiting
Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
Led by Second Xiangya Hospital of Central South University · Updated on 2024-08-29
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 return to normal rhythm
- At least two episodes of persistent atrial fibrillation in the past 6 months after 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
- Willing to receive medication or surgical treatment
- Willing to comply with study and follow-up requirements and sign informed consent
- Able to complete a 6-minute walk test
- For women of childbearing potential, negative pregnancy test required
You will not qualify if you...
- Presence of thrombus in the left atrium
- Left atrial diameter greater than 65 millimeters or volume over 200 milliliters
- Significant congenital abnormalities or medical issues unsuitable for study participation
- Reversible causes of atrial fibrillation like pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery or trauma
- Valvular heart disease requiring surgical intervention
- Coronary artery disease requiring surgical or percutaneous intervention
- History of atrioventricular node ablation
- Liver failure
- Renal failure requiring dialysis
- Contraindicated use of 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
AI-Screening
AI-Powered Screening
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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
CONTACT
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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