Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Suitable candidate for catheter ablation of atrial fibrillation defined as:

‣ history of symptomatic persistent atrial fibrillation

⁃ Redo procedure for persistent AF or paroxysmal AF with isolated PV and no history of ethanol infusion in the VOM.

• 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

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Pessac
Contact Information
Primary
Nicolas MD DERVAL
nicolas.derval@chu-bordeaux.fr
(0)5 57 65 64 71
Backup
Lorena SANCHEZ BLANCO
lorena.sanchez-blanco@chu-bordeaux.fr
(0)5 57 62 30 91
Time Frame
Start Date: 2022-05-09
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 40
Treatments
Experimental: Marshall ethanolisation with specific catheter
Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov