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In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALINE only group | Active Comparator | Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria |
|
| VoM group | Active Comparator | Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria and vein of Marshall (VoM) ethanol infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALINE + VoM infusion | Procedure | In patients assigned to the ALINE + VoM infusion group, extended ablation will be performed according to the ALINE criteria. Additionally, the vein of Marshall will be infused with ethanol. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural succes rate | Mitral isthmus block rate after one pass of the mitral line | At time of ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | At time of ablation | |
| Fluoroscopy time | At time of ablation | |
| Total RF ablation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastien Knecht, MD, PhD | AZ Sint-Lucas Brugge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge-Oostende AV | Bruges | 8000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35331432 | Derived | Gillis K, O'Neill L, Wielandts JY, Hilfiker G, Almorad A, Lycke M, El Haddad M, le Polain de Waroux JB, Tavernier R, Duytschaever M, Knecht S. Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation. JACC Clin Electrophysiol. 2022 Mar;8(3):367-376. doi: 10.1016/j.jacep.2021.11.019. Epub 2022 Feb 23. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ALINE only | Procedure | In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria. |
|
| At time of ablation |
| Total extent of ablated LA tissue | At time of ablation |
| Cardiovascular-related hospitalizations | From time of ablation to one month post procedure |
| Changes in quality of life (SF36) | From inclusion to one month post procedure |
| Incidence of atrial flutter | From time of ablation to one month post procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |