Status:
RECRUITING
Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Atrial Fibrillation, Persistent
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 pati...
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 ab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06578793
Start Date
August 1 2024
End Date
January 31 2026
Last Update
August 29 2024
Active Locations (1)
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1
Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011