NCT05427435 Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation
| NCT ID | NCT05427435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-05-09 |
| Primary Completion | 2027-05-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-05-09 with a primary completion date of 2027-05-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Nicolas MD DERVAL
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT05427435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05427435 currently recruiting?
Yes, NCT05427435 is actively recruiting participants. Contact the research team at nicolas.derval@chu-bordeaux.fr for enrollment information.
Where is the NCT05427435 trial being conducted?
This trial is being conducted at Pessac, France.
Who is sponsoring the NCT05427435 clinical trial?
NCT05427435 is sponsored by University Hospital, Bordeaux. The principal investigator is Nicolas MD DERVAL at Study Principal Investigator. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.