CHU de Bordeaux
Pessac, France
Location status: Recruiting
NCT Number: NCT05427435
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Pessac, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)
Time frame: 12 months
Success rate complete realization of ethanolization procedure
Time frame: 12 months
Time between the entry and the removal of the catheter
Time frame: 12 months
Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall
Time frame: 12 months
Time from the 1st injection of iodine to the 1st injection of ethanol
Time frame: 12 months
Time of exposure to X Ray and total of received radiation dose
Time frame: 12 months
Rate of Vein of Marshall dissection
Time frame: 12 months
Number and rate of adverse events related to ethanolization
Time frame: 12 months
Number and rate of adverse events related to the catheter or its procedure
Contact information is provided by the study sponsor or research team.
Lorena SANCHEZ BLANCO
CONTACT
(0)5 57 62 30 91 ext. +33
Nicolas MD DERVAL
CONTACT
(0)5 57 65 64 71 ext. +33
University Hospital, Bordeaux
Other
Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation
Acronym: Innov Marshall
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05378035
Arrhythmias, Cardiac, Arterial Thromboembolism
Hong Kong
View Trial DetailsNCT07492524
Arrhythmias, Cardiac, Atrial Fibrillation
Yancheng, Dongtai, China
View Trial DetailsNCT07492498
Arrhythmias, Cardiac, Atrial Fibrillation
Yancheng, Dongtai, China
View Trial DetailsNCT06099730
Arrhythmias, Cardiac, Atrial Fibrillation
Jonesboro, Arkansas, United States
View Trial Details