Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Recurrence of atrial tachyarrhythmias
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Jian Sun
Principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
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
Outcomes
Primary Outcomes
Recurrence of atrial tachyarrhythmias
Time Frame: 3 to 12 months
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Changes of low-voltage or scar area before and after VOMEI
Time Frame: 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
Time Frame: within 72 hours
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
Secondary Outcomes
- New low-voltage or scar area outside mitral isthmus and left pulmonary ridge(During the procedure)
- Rates of VOMEI incomplete(During the procedure)
- Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)(During the procedure)
- Burden of atrial tachyarrhythmia(12 months)
- Rates of mitral isthmus block(During the procedure)
- X ray exposure time(During the procedure)
- radiofrequency ablation time(During the procedure)
- procedure time(During the procedure)
- Recurrence of atrial flutter(3 to 12 months)
- Volume of ethanol and contrast agent used(During the procedure)