Clinical trial NCT05652517: Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
Official title: Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Changes of low-voltage or scar area before and after VOMEI
timeFrame: During the procedure
measure: Procedural complications
timeFrame: within 72 hours
measure: Recurrence of atrial tachyarrhythmias
timeFrame: 3 to 12 months
Secondary outcomes:
measure: Rates of mitral isthmus block
timeFrame: During the procedure
measure: New low-voltage or scar area outside mitral isthmus and left pulmonary ridge
timeFrame: During the procedure
measure: Rates of VOMEI incomplete
timeFrame: During the procedure
measure: X ray exposure time
timeFrame: During the procedure
measure: procedure time
timeFrame: During the procedure
measure: radiofrequency ablation time
timeFrame: During the procedure
measure: Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)
timeFrame: During the procedure
measure: Burden of atrial tachyarrhythmia
timeFrame: 12 months
measure: Recurrence of atrial flutter
timeFrame: 3 to 12 months
measure: Volume of ethanol and contrast agent used
timeFrame: During the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jian Sun
role: PRINCIPAL_INVESTIGATOR
References: