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In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set.
The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marshall ethanolisation with specific catheter | Experimental | Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marshall ethanolisation | Device | Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute success rate of the procedure | Success rate complete realization of ethanolization procedure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of ethanolization procedure | Time between the entry and the removal of the catheter | 12 months |
| Time to visualization of Vein of Marshall | Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall |
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Inclusion Criteria:
Suitable candidate for catheter ablation of atrial fibrillation defined as:
Age > 18 years of both genders
Patient affiliated or beneficiary of social security scheme
Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research)
Effective contraception for women of childbearing potential
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas MD DERVAL | Contact | (0)5 57 65 64 71 | +33 | nicolas.derval@chu-bordeaux.fr |
| Lorena SANCHEZ BLANCO | Contact | (0)5 57 62 30 91 | +33 | lorena.sanchez-blanco@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas MD DERVAL | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Recruiting | Pessac | France |
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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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prospective single arm monocentric evaluation study
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| 12 months |
| Duration of balloon positioning | Time from the 1st injection of iodine to the 1st injection of ethanol | 12 months |
| Total X Ray duration and radiation dose | Time of exposure to X Ray and total of received radiation dose | 12 months |
| Incidence of Vein of Marshall dissection | Rate of Vein of Marshall dissection | 12 months |
| Incidence of periprocedural complications related to ethanolization | Number and rate of adverse events related to ethanolization | 12 months |
| Incidence of complications related to catheter | Number and rate of adverse events related to the catheter or its procedure | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |