Clinical trial NCT06363604: Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of atrial arrhythmias
timeFrame: 3 and 12 months from the date of procedure
Secondary outcomes:
measure: Procedural complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiaotong University School of Medicine
name: Yigang LI, Dr.
role: PRINCIPAL_INVESTIGATOR
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