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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoroscopy-guided VOMEI | Active Comparator | Vein of Marshall ethanol infusion guided by fluoroscopy alone |
|
| UNIVU-guided VOMEI | Experimental | Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vein of Marshall ethanol infusion | Procedure | Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Procedural complications | Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death. | within 72 hours |
| Recurrence of atrial tachyarrhythmias | Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia | 3 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of mitral isthmus block | bidirectional block of mitral isthmus | During the procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu Chen, MD | Contact | 021-25077287 | chenmu@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Sun | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200092 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| During the procedure |
| Rates of VOMEI incomplete | Any reason leading to incomplete VOMEI | During the procedure |
| X ray exposure time | Procedure-related temporal parameters | During the procedure |
| procedure time | Procedure-related temporal parameters | During the procedure |
| radiofrequency ablation time | Procedure-related temporal parameters | During the procedure |
| Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion) | Termination of atrial fibrillation without cardioversion | During the procedure |
| Burden of atrial tachyarrhythmia | Evaluation by Holder monitoring at 12 months | 12 months |
| Recurrence of atrial flutter | recurrence of atrial flutter > 30 second by ECG or Holder monitoring | 3 to 12 months |
| Volume of ethanol and contrast agent used | ethanol volume, contrast agent volume used during the procedure | During the procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |