Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)

Persistent Atrial Fibrillation Clinical Trial

Official title:

Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652517
• Other study ID #: XH-22-009
• Status: Recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Mu Chen, MD
• Phone: 021-25077287
• Email: chenmu[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI.

Description:

A total of 100 participants with persistent or longstanding persistent AF who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive Vein of Marshall ethanol infusion (VOMEI).

Group 1: VOMEI guided by fluroscopy alone Group 2: VOMEI guided by fluoroscopy and CARTO UNIVU The intraprocedural major endpoints are the change in low-voltage area led by VOMEI (efficacy endpoint) and procedural complications (safety endpoint). The longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 85 years

• Sympathetic atrial fibrillation without previous ablation

• Persistent or long-standing persistent AF

• Patients' willing to undergo catheter ablation and VOMEI

Exclusion Criteria:

• Left atrial or left atrial appendage thrombus

• LVEF <30%

• Cardiac surgery within 90 days

• Myocardial infarction within 90 days

• PCI or PTCA within 90 days

• Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism

• Atrial myxoma

• Congenital heart disease

• Pregnant or pregnant plan

• Acute or severe infection

• Creatine> 221 µmol/L, or GFR <30 ml/min/1.73 m.

• Unstable angina

• Blood-clotting or bleeding disorder

• Contraindication to anticoagulation

• Life expectancy less than 1 year

• Uncontrolled heart failure

• Uncontrolled malignant tumor

• Malformation of femoral vascular access

• Without consent

Related Conditions & MeSH terms

• Atrial Fibrillation
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Vein of Marshall ethanol infusion
Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.

Locations

Country	Name	City	State
China	Xinhua hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of low-voltage or scar area before and after VOMEI	Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI	During the procedure
Primary	Procedural complications	Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.	within 72 hours
Primary	Recurrence of atrial tachyarrhythmias	Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia	3 to 12 months
Secondary	Rates of mitral isthmus block	bidirectional block of mitral isthmus	During the procedure
Secondary	New low-voltage or scar area outside mitral isthmus and left pulmonary ridge	New low-voltage or scar area after VOMEI outside the targeted regions	During the procedure
Secondary	Rates of VOMEI incomplete	Any reason leading to incomplete VOMEI	During the procedure
Secondary	X ray exposure time	Procedure-related temporal parameters	During the procedure
Secondary	procedure time	Procedure-related temporal parameters	During the procedure
Secondary	radiofrequency ablation time	Procedure-related temporal parameters	During the procedure
Secondary	Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)	Termination of atrial fibrillation without cardioversion	During the procedure
Secondary	Burden of atrial tachyarrhythmia	Evaluation by Holder monitoring at 12 months	12 months
Secondary	Recurrence of atrial flutter	recurrence of atrial flutter > 30 second by ECG or Holder monitoring	3 to 12 months
Secondary	Volume of ethanol and contrast agent used	ethanol volume, contrast agent volume used during the procedure	During the procedure