Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation
Recruiting · NCT06363604 · Interventional (participants receive a specific treatment) · Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Posterior wall isolationVOMEI + PVI + linear ablation of mitral isthmus
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Between 18-85 years old;
- Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug;
- Prepared to undergo atrial fibrillation catheter ablation;
- Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.
Exclusion criteria
- 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;
- On the heart transplant list;
- Life expectancy less than 1 year;
- With other bleeding disorders that cannot be treated with anticoagulation therapy;
- With left atrial thrombus;
- Heart failure with NYHA class III-IV or LVEF\<40%;
- With uncontrolled malignant tumor;
- Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr\<50%);
- History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;
- Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.
Where it is running
1 location listed.
- Xinhua Hospital, Shanghai Jiao Tong University - Shanghai, Shanghai Municipality, China