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New treatment option for Atrial Fibrillation
Official title Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation
ClinicalTrials.gov ID: NCT05427435
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Hypersensitivity to ethanol
- Unstable angina or ongoing myocardial ischemia
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Pessac, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pessac, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.