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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation combined with Marshall vein ethanol ablation group | Experimental | Participants in this group will undergo standard catheter ablation, which involves the isolation of the pulmonary veins and may include additional ablation of other atrial areas as necessary, guided by fluoroscopy and/or 3D electroanatomical mapping. In addition to the standard ablation procedure, participants will receive Marshall vein ethanol ablation. This involves the injection of absolute ethanol into the Marshall vein via a specialized catheter, aiming to ablate the vein's myocardial sleeves and adjacent autonomic fibers. The ethanol ablation targets arrhythmogenic substrates and aims to enhance the efficacy of the overall ablation procedure by reducing atrial fibrillation triggers. This combined approach is hypothesized to improve clinical outcomes by providing a more comprehensive treatment of atrial fibrillation substrates, particularly in patients with persistent atrial fibrillation and concomitant heart failure. |
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| Catheter ablation alone group | Active Comparator | Participants in this group will undergo standard catheter ablation, which primarily involves the isolation of the pulmonary veins, a common trigger site for atrial fibrillation. The procedure may include additional ablation of other atrial areas based on the patient's specific arrhythmogenic substrate. The catheter ablation will be performed under fluoroscopic guidance and/or with the assistance of 3D electroanatomical mapping to ensure precision. This procedure is designed to eliminate or reduce the arrhythmogenic tissue within the atria to restore and maintain normal sinus rhythm. This intervention is the comparator arm in the study, representing the current standard treatment for persistent atrial fibrillation, particularly in patients with concomitant heart failure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation Combined with Marshall Vein Ethanol Ablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence | 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. | 12 months after the procedure |
| Change in NT-proBNP Levels | 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. | 12 months after the procedure |
| Change in Left Ventricular Ejection Fraction (LVEF) | This outcome assesses the change in LVEF as measured by echocardiography, reflecting the effect of the intervention on cardiac function. | 12 months after the procedure |
| Change in 6-Minute Walk Test Distance | This outcome measures the change in the distance covered during the 6-minute walk test, an indicator of functional capacity and exercise tolerance. | 12 months after the procedure |
| Change in NYHA Functional Class | This outcome evaluates changes in the New York Heart Association (NYHA) functional classification, which assesses the severity of heart failure symptoms and functional limitations. | 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or Absence of Arrhythmias Within 30 Days | This outcome measures whether arrhythmias related to the procedure occurred within 30 days post-intervention. | 30 days after the procedure |
| Presence or Absence of Chest Tightness Within 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Xuping | Contact | 3973183686 | lixp0711@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
There is no plan to share individual participant data (IPD) from this study with other researchers. The data will be used exclusively by the research team for the purposes of this study and will not be made available to third parties.
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This outcome measures whether chest tightness related to the procedure occurred within 30 days post-intervention.
| 30 days after the procedure |
| Presence or Absence of Palpitations Within 30 Days | This outcome measures whether palpitations related to the procedure occurred within 30 days post-intervention. | 30 days after the procedure |
| Presence or Absence of Bleeding Within 30 Days | This outcome measures whether bleeding related to the procedure occurred within 30 days post-intervention. | 30 days after the procedure |
| Presence or Absence of Mortality Within 30 Days | This outcome measures whether mortality related to the procedure occurred within 30 days post-intervention. | 30 days after the procedure |
| Atrial Fibrillation Burden at 6 Months | This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 6 months post-intervention. | 6 months after the procedure |
| Atrial Fibrillation Burden at 12 Months | This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 12 months post-intervention. | 12 months after the procedure |
| Total Number of Procedures Performed | This outcome measures the total number of procedures performed during the intervention. | During the procedure(s) |
| Total Radiofrequency Ablation Time for the First Procedure | This outcome measures the total radiofrequency ablation time during the first procedure. | During the first procedure |
| Total Radiofrequency Ablation Time for the Second Procedure (if applicable) | This outcome measures the total radiofrequency ablation time during the second procedure, if applicable. | During the second procedure |
| Total Area of Left Atrial (LA) Tissue Ablated | This outcome measures the total area of left atrial (LA) tissue ablated during the procedure(s). | During the procedure(s) |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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