Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Fluoroscopy-guided VOMEI Vein of Marshall ethanol infusion guided by fluoroscopy alone |
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.
|
| Experimental: UNIVU-guided VOMEI Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy |
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.
|
Outcome Measures
Primary Outcome Measures
- Changes of low-voltage or scar area before and after VOMEI [During the procedure]
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
- Procedural complications [within 72 hours]
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
- Recurrence of atrial tachyarrhythmias [3 to 12 months]
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Secondary Outcome Measures
- Rates of mitral isthmus block [During the procedure]
bidirectional block of mitral isthmus
- New low-voltage or scar area outside mitral isthmus and left pulmonary ridge [During the procedure]
New low-voltage or scar area after VOMEI outside the targeted regions
- Rates of VOMEI incomplete [During the procedure]
Any reason leading to incomplete VOMEI
- X ray exposure time [During the procedure]
Procedure-related temporal parameters
- procedure time [During the procedure]
Procedure-related temporal parameters
- radiofrequency ablation time [During the procedure]
Procedure-related temporal parameters
- Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion) [During the procedure]
Termination of atrial fibrillation without cardioversion
- Burden of atrial tachyarrhythmia [12 months]
Evaluation by Holder monitoring at 12 months
- Recurrence of atrial flutter [3 to 12 months]
recurrence of atrial flutter > 30 second by ECG or Holder monitoring
- Volume of ethanol and contrast agent used [During the procedure]
ethanol volume, contrast agent volume used during the procedure
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 85 years
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Sympathetic atrial fibrillation without previous ablation
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Persistent or long-standing persistent AF
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Patients' willing to undergo catheter ablation and VOMEI
Exclusion Criteria:
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Left atrial or left atrial appendage thrombus
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LVEF <30%
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Cardiac surgery within 90 days
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Myocardial infarction within 90 days
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PCI or PTCA within 90 days
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Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism
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Atrial myxoma
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Congenital heart disease
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Pregnant or pregnant plan
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Acute or severe infection
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Creatine> 221 μmol/L, or GFR <30 ml/min/1.73 m.
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Unstable angina
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Blood-clotting or bleeding disorder
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Contraindication to anticoagulation
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Life expectancy less than 1 year
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Uncontrolled heart failure
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Uncontrolled malignant tumor
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Malformation of femoral vascular access
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Without consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xinhua hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China | 200092 |
Sponsors and Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
- Principal Investigator: Jian Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XH-22-009