Clinical trial NCT05427435: Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Persistent atrial fibrillation
Pulmonary vein isolation
Catheter ablation
Ethanolization
Ligament of Marshall
Vein of Marshall
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective single arm monocentric evaluation study
Primary purpose: PREVENTION

Brief 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 criteria: 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)

Primary outcomes:
measure: Acute success rate of the procedure
timeFrame: 12 months
Secondary outcomes:
measure: Total duration of ethanolization procedure
timeFrame: 12 months
measure: Time to visualization of Vein of Marshall
timeFrame: 12 months
measure: Duration of balloon positioning
timeFrame: 12 months
measure: Total X Ray duration and radiation dose
timeFrame: 12 months
measure: Incidence of Vein of Marshall dissection
timeFrame: 12 months
measure: Incidence of periprocedural complications related to ethanolization
timeFrame: 12 months
measure: Incidence of complications related to catheter
timeFrame: 12 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: Study Principal Investigator
name: Nicolas MD DERVAL
role: PRINCIPAL_INVESTIGATOR
References: