Randomized Controlled Study of Atrial Posterior Wall Isolation (PWI) Assisted by Vein of Marshall Ethanol Infusion (VOMEI) and Pulmonary Vein Isolation in Persistent Atrial Fibrillation Ablation
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Xinhua Hospital, Shanghai Jiao Tong University
RECRUITING
Shanghai
Contact Information
Primary
Yichi YU, Dr.
yuyichi@xinhuamed.com.cn
+8613585563975
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 260
Treatments
Experimental: VOMEI + PVI + linear ablation of mitral isthmus + PWI
Acquisition of left atrial posterior wall isolation by linear ablation of LA roof and bottom line, in addition to routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus.
Active_comparator: VOMEI + PVI + linear ablation of mitral isthmus
Routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus. Left atrial posterior wall not isolated.
Related Therapeutic Areas
Sponsors
Leads: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine