Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05427435

Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation

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
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEMarshall ethanolisationDestruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)

Timeline

Start date
2022-05-09
Primary completion
2027-05-16
Completion
2027-05-30
First posted
2022-06-22
Last updated
2025-06-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05427435. Inclusion in this directory is not an endorsement.