Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT06363604
- Run by
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 260
- Starts
- 2023-12-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2024-04-12
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Xinhua Hospital, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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