Atrial Fibrillation
Conditions
Brief summary
This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation.
Detailed description
A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio. Group 1: VOMEI + PVI + linear ablation + PWI; Group 2: VOMEI + PVI +linear ablation. The major endpoint (efficacy endpoint) is the recurrence of atrial tachyarrhythmias between 3-12 months during follow-up. The secondary endpoint (safety endpoint) is the occurrence of procedural complications.
Interventions
PROCEDUREVOMEI + PVI + linear ablation of mitral isthmus
The CS angiography is firstly performed to visualize the vein of Marshall. The ethanol infusion by anhydrous alcohol is then performed by using a guidewire and an OTW ballon. For radiofrequency catheter ablation, the standard procedure of pulmonary vein isolation is performed. All the enrolled persistent AF patients perform the routine linear ablation of mitral isthmus.
PROCEDUREPosterior wall isolation
PWI is additionally performed for experimental group with linear ablation of LA roof and bottom line, and verified by mapping with a multielectrode catheter.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation.
Intervention model description
A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio. Group 0 (Control): VOMEI + PVI + linear ablation of mitral isthmus. Group 1 (Experimental): VOMEI + PVI + linear ablation of mitral isthmus + PWI
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between 18-85 years old; 2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug; 3. Prepared to undergo atrial fibrillation catheter ablation; 4. Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.
Exclusion criteria
1. Presence of acute conditions such as acute phase after myocardial infarction (within 3 months), acute heart failure or new onset of cerebral infarction within 3 months; 2. On the heart transplant list; 3. Life expectancy less than 1 year; 4. With other bleeding disorders that cannot be treated with anticoagulation therapy; 5. With left atrial thrombus; 6. Heart failure with NYHA class III-IV or LVEF\<40%; 7. With uncontrolled malignant tumor; 8. Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr\<50%); 9. History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery; 10. Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial arrhythmias | 3 and 12 months from the date of procedure | Efficacy endpoint: Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (sustaining more than 30s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural complications | through study completion, an average of 1 year | Safety endpoint: Occurrence of of atrioesophageal fistula, pulmonary vein stenosis, pericardial tamponade, phrenic nerve injury, and embolism |
Countries
China
Contacts
Primary ContactYichi YU, Dr.
Outcome results
None listed