Atrial Fibrillation
Conditions
Keywords
Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolization, Ligament of Marshall, Vein of Marshall
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.
Interventions
DEVICEMarshall ethanolisation
Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
prospective single arm monocentric evaluation study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute success rate of the procedure | 12 months | Success rate complete realization of ethanolization procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to visualization of Vein of Marshall | 12 months | Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall |
| Duration of balloon positioning | 12 months | Time from the 1st injection of iodine to the 1st injection of ethanol |
| Total X Ray duration and radiation dose | 12 months | Time of exposure to X Ray and total of received radiation dose |
| Total duration of ethanolization procedure | 12 months | Time between the entry and the removal of the catheter |
| Incidence of periprocedural complications related to ethanolization | 12 months | Number and rate of adverse events related to ethanolization |
| Incidence of complications related to catheter | 12 months | Number and rate of adverse events related to the catheter or its procedure |
| Incidence of Vein of Marshall dissection | 12 months | Rate of Vein of Marshall dissection |
Countries
France
Contacts
Primary ContactNicolas MD DERVAL
Backup ContactLorena SANCHEZ BLANCO
Outcome results
None listed