Clinical trial NCT06578793: Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
Official title: Comparison of Catheter Ablation Combined With Ethanol Ablation of the Marshall Vein vs. Catheter Ablation Alone in Persistent Atrial Fibrillation With Heart Failure: A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Heart Failure
Keywords: Atrial Fibrillation
Heart Failure
Catheter Ablation
Marshall Vein
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence
timeFrame: 12 months after the procedure
measure: Change in NT-proBNP Levels
timeFrame: 12 months after the procedure
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: 12 months after the procedure
measure: Change in 6-Minute Walk Test Distance
timeFrame: 12 months after the procedure
measure: Change in NYHA Functional Class
timeFrame: 12 months after the procedure
Secondary outcomes:
measure: Presence or Absence of Arrhythmias Within 30 Days
timeFrame: 30 days after the procedure
measure: Presence or Absence of Chest Tightness Within 30 Days
timeFrame: 30 days after the procedure
measure: Presence or Absence of Palpitations Within 30 Days
timeFrame: 30 days after the procedure
measure: Presence or Absence of Bleeding Within 30 Days
timeFrame: 30 days after the procedure
measure: Presence or Absence of Mortality Within 30 Days
timeFrame: 30 days after the procedure
measure: Atrial Fibrillation Burden at 6 Months
timeFrame: 6 months after the procedure
measure: Atrial Fibrillation Burden at 12 Months
timeFrame: 12 months after the procedure
measure: Total Number of Procedures Performed
timeFrame: During the procedure(s)
measure: Total Radiofrequency Ablation Time for the First Procedure
timeFrame: During the first procedure
measure: Total Radiofrequency Ablation Time for the Second Procedure (if applicable)
timeFrame: During the second procedure
measure: Total Area of Left Atrial (LA) Tissue Ablated
timeFrame: During the procedure(s)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: