Atrial Fibrillation, Persistent, Heart Failure
Conditions
Keywords
Atrial Fibrillation, Heart Failure, Catheter Ablation, Marshall Vein
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 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.
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 ablation is widely used to manage AF, but its efficacy in persistent AF, particularly in patients with heart failure, is limited. Recent advances suggest that targeting the Marshall vein with ethanol ablation may offer additional benefits by disrupting critical pathways involved in AF maintenance. This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population. Conducted across three centers, this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes, including lower AF recurrence rates and improved heart function. The study's findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group.
Interventions
PROCEDURECatheter Ablation Combined with Marshall Vein Ethanol Ablation
This study involves two procedures. The first procedure is a combination of catheter ablation with ethanol ablation of the Marshall vein. The second procedure is catheter ablation alone. Both procedures involve standard techniques used to treat persistent atrial fibrillation, with the addition of Marshall vein ethanol ablation in the experimental group aimed at potentially improving outcomes by targeting additional arrhythmogenic substrates.
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence | 12 months after the procedure | The primary outcome is the proportion of participants who remain free from clinical recurrence of atrial fibrillation (AF) or atrial flutter (AFL) at follow-up. Recurrence is defined as the absence of documented AF/AFL episodes lasting 30 seconds or more during continuous ECG monitoring over a 1-month period. |
| Change in NT-proBNP Levels | 12 months after the procedure | This outcome measures the change in NT-proBNP levels, a biomarker for heart failure, from baseline to follow-up, indicating the impact of the intervention on heart failure status. |
| Change in Left Ventricular Ejection Fraction (LVEF) | 12 months after the procedure | This outcome assesses the change in LVEF as measured by echocardiography, reflecting the effect of the intervention on cardiac function. |
| Change in 6-Minute Walk Test Distance | 12 months after the procedure | This outcome measures the change in the distance covered during the 6-minute walk test, an indicator of functional capacity and exercise tolerance. |
| Change in NYHA Functional Class | 12 months after the procedure | This outcome evaluates changes in the New York Heart Association (NYHA) functional classification, which assesses the severity of heart failure symptoms and functional limitations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Burden at 6 Months | 6 months after the procedure | This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 6 months post-intervention. |
| Atrial Fibrillation Burden at 12 Months | 12 months after the procedure | This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 12 months post-intervention. |
| Total Number of Procedures Performed | During the procedure(s) | This outcome measures the total number of procedures performed during the intervention. |
| Presence or Absence of Arrhythmias Within 30 Days | 30 days after the procedure | This outcome measures whether arrhythmias related to the procedure occurred within 30 days post-intervention. |
| Total Radiofrequency Ablation Time for the Second Procedure (if applicable) | During the second procedure | This outcome measures the total radiofrequency ablation time during the second procedure, if applicable. |
| Total Area of Left Atrial (LA) Tissue Ablated | During the procedure(s) | This outcome measures the total area of left atrial (LA) tissue ablated during the procedure(s). |
| Total Radiofrequency Ablation Time for the First Procedure | During the first procedure | This outcome measures the total radiofrequency ablation time during the first procedure. |
| Presence or Absence of Chest Tightness Within 30 Days | 30 days after the procedure | This outcome measures whether chest tightness related to the procedure occurred within 30 days post-intervention. |
| Presence or Absence of Palpitations Within 30 Days | 30 days after the procedure | This outcome measures whether palpitations related to the procedure occurred within 30 days post-intervention. |
| Presence or Absence of Bleeding Within 30 Days | 30 days after the procedure | This outcome measures whether bleeding related to the procedure occurred within 30 days post-intervention. |
| Presence or Absence of Mortality Within 30 Days | 30 days after the procedure | This outcome measures whether mortality related to the procedure occurred within 30 days post-intervention. |
Countries
China
Contacts
Primary ContactLi Xuping
Outcome results
None listed