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

NCT06578793 | Recruiting

• 1 other identifier: XYSY_CAB_MVA_2024_001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation, Persistent; Heart Failure

Keywords

Atrial Fibrillation; Heart Failure; Catheter Ablation; Marshall Vein

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (11)

• Presence or Absence of Arrhythmias Within 30 Days

  30 days after the procedure

• Presence or Absence of Chest Tightness Within 30 Days

  30 days after the procedure

• Presence or Absence of Palpitations Within 30 Days

  30 days after the procedure

• Presence or Absence of Bleeding Within 30 Days

  30 days after the procedure

• Presence or Absence of Mortality Within 30 Days

  30 days after the procedure

Study Arms (2)

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.

Procedure: Catheter Ablation Combined with Marshall Vein Ethanol Ablation

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.

Procedure: Catheter Ablation Combined with Marshall Vein Ethanol Ablation

Interventions

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.

Also known as: Catheter Ablation Alone

Catheter ablation alone group; Catheter ablation combined with Marshall vein ethanol ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Li Xuping

CONTACT

3973183686; lixp0711@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 29, 2024
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)