Comparing catheter ablation with and without Marshall vein ethanol ablation for persistent atrial fibrillation and heart failure
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
This study is testing if adding a special treatment to catheter ablation can help people with persistent atrial fibrillation and heart failure feel better and have fewer heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06578793 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial aims to evaluate the effectiveness and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients suffering from persistent atrial fibrillation (AF) and heart failure. The study will enroll 120 participants across three centers and focus on whether the addition of Marshall vein ethanol ablation can reduce AF recurrence and improve heart function. By targeting arrhythmogenic substrates, this approach seeks to enhance treatment outcomes for a patient population that faces significant morbidity and mortality. The findings are expected to provide valuable insights into optimizing treatment strategies for these high-risk patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with persistent atrial fibrillation and heart failure, characterized by a left ventricular ejection fraction of 40% or less.
Not a fit: Patients with thrombus in the left atrium or a left atrial diameter greater than 65 mm may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with persistent atrial fibrillation and heart failure.
How similar studies have performed: While catheter ablation is a standard treatment for atrial fibrillation, the combination with Marshall vein ethanol ablation is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Changsha, Hunan
- Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Li Xuping
- Email: lixp0711@126.com
- Phone: 3973183686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.