New approach to treat persistent atrial fibrillation using ethanol infusion and ablation techniques
Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation
This study is testing a new way to treat persistent atrial fibrillation by combining a common heart procedure with a special ethanol infusion to see if it helps patients feel better and reduces the chances of their symptoms coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 9 sites (Brugge and 8 other locations) |
| Trial ID | NCT04681872 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel ablation strategy for persistent atrial fibrillation (PsAF) that combines pulmonary vein isolation with targeted ethanol infusion into the ligament of Marshall. The aim is to improve the success rate of catheter ablation by addressing arrhythmogenic structures that contribute to the condition. The study will enroll patients who have experienced symptomatic PsAF and are suitable candidates for catheter ablation. The methodology includes systematic targeting of the Marshall network alongside traditional ablation techniques to reduce recurrence rates post-procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a documented history of symptomatic persistent atrial fibrillation.
Not a fit: Patients who have previously undergone left atrial ablation or have contraindications to anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the long-term outcomes for patients suffering from persistent atrial fibrillation.
How similar studies have performed: While traditional ablation strategies have shown variable success, this novel approach targeting the ligament of Marshall has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years of both genders * Suitable candidate for catheter and ablation of atrial fibrillation defined as: history of symptomatic persistent atrial fibrillation in the past year documented by ECG, * 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: * Prior left atrial heart ablation procedure, * 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 products (history of major immediate reaction, thyrotoxicosis), * Ethanol hypersensitivity, * 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, * Hypertrophic cardiomyopathy defined by a left ventricular septum thickness \> 1.5 cm, * Pregnant, parturient or nursing women, * Person unable to give informed consent, * Patient detained by judicial or administrative order, patient under legal protection (guardianship, curators, safeguarding justice).
Where this trial is running
Brugge and 8 other locations
- AZ Sint Jan Brugge — Brugge, Belgium (Not_yet_recruiting)
- Clinique Saint Augustin — Bordeaux, France (Active_not_recruiting)
- Clermont-Ferrand University Hospital — Clermont-Ferrand, France (Recruiting)
- Ambroise Paré Hospital — Neuilly-sur-Seine, France (Recruiting)
- Les Franciscaines Hospital — Nîmes, France (Recruiting)
- Bordeaux University Hospital — Pessac, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- Toulouse University Hospirtal — Toulouse, France (Active_not_recruiting)
Study contacts
- Principal investigator: Nicolas DERVAL, MD — University Hospital, Bordeaux
- Study coordinator: Nicolas DERVAL, MD
- 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.