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

NCT ID: NCT06578793

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-01-31

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.

Conditions

Atrial Fibrillation, Persistent; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Catheter ablation combined with Marshall vein ethanol ablation group

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.

Group Type: EXPERIMENTAL

Catheter Ablation Combined with Marshall Vein Ethanol Ablation

Intervention Type: 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.

Catheter ablation alone group

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.

Group Type: ACTIVE_COMPARATOR

Catheter Ablation Combined with Marshall Vein Ethanol Ablation

Intervention Type: 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.

Interventions

Catheter 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.

Intervention Type: PROCEDURE

Other Intervention Names

Catheter Ablation Alone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Li Xuping

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Xuping

Role: CONTACT

lixp0711@126.com

3973183686

Facility Contacts

Li Xuping, PhD

Role: primary

lixp0711@126.com

13973183686

Other Identifiers

XYSY_CAB_MVA_2024_001

Identifier Type: -

Identifier Source: org_study_id