Using a special catheter to treat persistent atrial fibrillation by targeting the vein of Marshall
Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation
NA · University Hospital, Bordeaux · NCT05427435
This study is testing a special catheter to see if targeting a specific vein can help people with persistent atrial fibrillation feel better after their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Pessac) |
| Trial ID | NCT05427435 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using a specific catheter, the Targeted Endovascular Delivery (TED) catheter, to visualize and ethanolize the vein of Marshall in patients with persistent atrial fibrillation (PsAF). The aim is to systematically include this highly arrhythmogenic structure in the ablation procedure, which may improve outcomes compared to traditional pulmonary vein isolation alone. The study will enroll suitable candidates who have a history of symptomatic PsAF and are undergoing catheter ablation. Participants will be monitored for the effectiveness of this novel approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with symptomatic persistent atrial fibrillation or those undergoing a redo procedure for persistent or paroxysmal atrial fibrillation.
Not a fit: Patients with contraindications to anticoagulation therapy or those with documented left atrial thrombus will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the rate of arrhythmia freedom in patients with persistent atrial fibrillation.
How similar studies have performed: While traditional approaches have shown limited success, this specific method targeting the vein of Marshall is novel and has not been systematically tested before.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Pessac
- CHU de Bordeaux — Pessac, France (RECRUITING)
Study contacts
- Principal investigator: Nicolas MD DERVAL — Study Principal Investigator
- Study coordinator: Nicolas MD DERVAL
- Email: nicolas.derval@chu-bordeaux.fr
- Phone: (0)5 57 65 64 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolization, Ligament of Marshall, Vein of Marshall