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

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach for treating persistent atrial fibrillation (AF) in patients who also have heart failure. Atrial fibrillation is an irregular heartbeat that can cause symptoms like fatigue and shortness of breath, especially in people with heart issues. The trial is comparing two treatment methods: one combines a standard procedure called catheter ablation with a new technique called Marshall vein ethanol ablation, while the other uses catheter ablation alone. Researchers want to see if the combined treatment can reduce the recurrence of AF and improve heart function better than the standard method by itself.

To participate in this trial, individuals should be between 18 and 80 years old and have a history of persistent atrial fibrillation for at least six months, along with heart failure that has been confirmed by a heart ultrasound. Participants will need to be able to complete a simple walking test and agree to follow the study's requirements. The trial is currently recruiting participants, and it aims to enroll 120 people across three different medical centers. This study could offer insights into more effective treatments for those dealing with both AF and heart failure.

Gender

ALL

Eligibility 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