An interventional study of Marshall ethanolisation in Atrial Fibrillation, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 40 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Suitable candidate for catheter ablation of atrial fibrillation defined as:
Exclusion Criteria:
Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter
Device: Marshall ethanolisation
Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)
Acute success rate of the procedure
Success rate complete realization of ethanolization procedure
Time frame: 12 months
Total duration of ethanolization procedure
Time between the entry and the removal of the catheter
Time frame: 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
Time frame: 12 months
Duration of balloon positioning
Time from the 1st injection of iodine to the 1st injection of ethanol
Time frame: 12 months
Total X Ray duration and radiation dose
Time of exposure to X Ray and total of received radiation dose
Time frame: 12 months
Incidence of Vein of Marshall dissection
Rate of Vein of Marshall dissection
Time frame: 12 months
Incidence of periprocedural complications related to ethanolization
Number and rate of adverse events related to ethanolization
Time frame: 12 months
Incidence of complications related to catheter
Number and rate of adverse events related to the catheter or its procedure
Time frame: 12 months
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University Hospital, Bordeaux