Longstanding Persistent Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREVein of Marshall ethanol infusion
Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 mitral isthmus block | During the procedure | bidirectional block of mitral isthmus |
| 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 |
| Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion) | During the procedure | Termination of atrial fibrillation without cardioversion |
| 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 |
Countries
China
Contacts
Primary ContactMu Chen, MD
Outcome results
None listed