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

Atrial Fibrillation Clinical Trial

— Innov Marshall  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427435
• Other study ID #: CHUBX 2021/18
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: May 30, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Bordeaux
• Contact: Nicolas MD DERVAL
• Phone: (0)5 57 65 64 71
• Email: nicolas.derval[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2025
• Est. primary completion date: May 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Minor

• Documented left atrial thrombus or another abnormality which precludes catheter introduction

• Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]

• Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensivity or at one of these excipients, history of major immediate reaction or cutaneous reaction to XENETIX® infusion, thyrotoxicosis)

• Hypersensitivity to ethanol

• Unstable angina or ongoing myocardial ischemia

• Myocardial infarction within 3 months prior to inclusion

• Congenital heart disease, where the underlying abnormality increases the ablation risk

• Severe bleeding, clotting or thrombotic disorder

• Pregnant, parturient or nursing women

• Unable or unwilling to provide written informed consent

• Patient detained by judicial or administrative order

• Patient under psychiatric care

• Patient admitted in a social or healthcare establishment for any purpose other than the research

• Subject to a legal protection order (guardianship, patient under legal protection)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Marshall ethanolisation
Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)

Locations

Country	Name	City	State
France	CHU de Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute success rate of the procedure	Success rate complete realization of ethanolization procedure	12 months
Secondary	Total duration of ethanolization procedure	Time between the entry and the removal of the catheter	12 months
Secondary	Time to visualization of Vein of Marshall	Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall	12 months
Secondary	Duration of balloon positioning	Time from the 1st injection of iodine to the 1st injection of ethanol	12 months
Secondary	Total X Ray duration and radiation dose	Time of exposure to X Ray and total of received radiation dose	12 months
Secondary	Incidence of Vein of Marshall dissection	Rate of Vein of Marshall dissection	12 months
Secondary	Incidence of periprocedural complications related to ethanolization	Number and rate of adverse events related to ethanolization	12 months
Secondary	Incidence of complications related to catheter	Number and rate of adverse events related to the catheter or its procedure	12 months