RECRUITINGINTERVENTIONAL

Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form to participate in the study, comply with follow-up trials and evaluation procedures. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

VOMEI + 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.

PROCEDURE

Posterior 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.

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China