NCT04681872Active, not recruiting
Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free 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 incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 262 (actual)
- First submitted
- 18 Dec 2020
- Start date
- 20 Sept 2021
- Primary completion date
- 20 Sept 2027
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Atrial fibrillation
- NCT number
- NCT04681872
What you commit to
- Study type: Interventional
- Participants enrolled: 262
- From 20 Sept 2021 to the primary completion date, 20 Sept 2027
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrial heart ablation procedure,
- Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant (NOAC)),
- Myocardial infarction within 3 months prior to inclusion,
Other illness
- Contraindication to iodinated contrast products (history of major immediate reaction, thyrotoxicosis),
- Ethanol hypersensitivity,
- Unstable angina or ongoing myocardial ischemia,
- Congenital heart disease, where the underlying abnormality increases the ablation risk,
- Severe bleeding, clotting or thrombotic disorder,
Other
- Documented left atrial thrombus or another abnormality which precludes catheter introduction,
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Clinique Saint Augustin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Clermont-Ferrand University Hospital Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Ambroise Paré Hospital Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Unknown status |
| Les Franciscaines Hospital Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Bordeaux University Hospital Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Toulouse University Hospirtal Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
Related publications
- Marshall-Plan ablation strategy versus pulmonary vein isolation in persistent atrial fibrillation: Clinical trial design.Am Heart J · 2026 · PMID 41951089
This page is information, not medical advice. Discuss any trial with your doctor.