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Empirical Marshall vein ethanol infusion in Persistent atrial fibrillation patients who undergoing catheter ablation at mitral isthmus: the EMPIRICAL study

Empirical Marshall vein ethanol infusion in Persistent atrial fibrillation patients who undergoing catheter ablation at mitral isthmus: the EMPIRICAL study - the EMPIRICAL study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080587
Enrollment
Unknown
Registered
2024-02-01
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent atrial fibrillation

Interventions

Empirical MVEI Group:During the operation, coronary sinus angiography is performed to confirm VOM anatomy and localization. Three-dimensional modeling of the left atrium and voltage mapping before MVE
Provisional MVEI Group:During the operation, coronary sinus angiography is performed to confirm VOM anatomy and localization. After puncturing the atrial septum, three-dimensional modeling of the left
endocardial linear ablation of the left atrial including the mitral isthmus line is performed, and ablation could be performed in the epicardial surface corresponding to the coronary sinus if necessa

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients who met the diagnostic criteria for non-valvular atrial fibrillation in the 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation were enrolled; (2) According to medical history, physical examination, 12-lead electrocardiogram, 24-hour electrocardiogram, transthoracic echocardiography, in line with the diagnostic criteria of persistent atrial fibrillation; (3) The presence of Marshall vein was confirmed by coronary sinus angiography; (4) Aged over 18 years; (5) Subjects or their families voluntarily accept the clinical trial and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have previously undergone atrial fibrillation ablation and cardiac surgery; (2) Congenital heart disease, valvular heart disease, angina pectoris, myocardial infarction, myocarditis, cardiomyopathy, pulmonary heart disease, severe liver and kidney dysfunction, severe infection, autoimmune diseases, blood system diseases, malignant tumors; (3) Cardiac function (NYHA New York Heart Association functional classification) class III or above, echocardiography showed left ventricular ejection fraction = 40%; (4) Presence of serious nervous system diseases (nervous system infection, etc.), mental illness (including drug abuse, chronic alcoholism, etc.); (5) Pregnant and lactating women; (6) Participated in other clinical studies within 3 months prior to the informed consent date, or is participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Recurrence of atrial tachyarrhythmias after the 3-month blanking period;Amount of ethanol ablated by MVEI;

Secondary

MeasureTime frame
Mitral isthmus ablation time;Radiofrequency ablation time;Total operation time;X-ray exposure time and doseage;Contrast agent dosage;Atrial Arrhythmia Termination Mode;Safety Endpoints;

Countries

China

Contacts

Public ContactXianfeng Du

The First Affiliated Hospital of Ningbo University

drduxianfeng@126.com+86 574 8708 5226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026