NCT04206982Completed
MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial
MARSHALL Bundles Elimination, Pulmonary Veins Isolation and Lines Completion for ANatomical Ablation of Persistent Atrial Fibrillation Versus Pulmonary Veins Isolation: The MARSHALL PLAN Monocentric Trial
Source: ClinicalTrials.gov · Last updated 17 Jun 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). The main objective of this study is to compare the 12 month freedom from any arrhythmia (Atrial Fibrillation (AF)/Atrial Tachycardia (AT)) between the Marshall-Plan approach and the PV isolation approach.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 18 Dec 2019
- Start date
- 22 Jan 2020
- Primary completion date
- 23 Nov 2023
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Atrial fibrillation
- NCT number
- NCT04206982
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 22 Jan 2020 to the primary completion date, 23 Nov 2023
- 1 site in 1 country
- 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
- Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) \> 200 mm Hg within 30 days prior to inclusion
Other illness
- Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensitivity 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
- Congenital heart disease, where the underlying abnormality increases the ablation risk
- Pulmonary hypertension (pulmonary arterial hypertension \> 50 mmHg)
- Severe bleeding, clotting or thrombotic disorder
- Patient under psychiatric care
Other
- Minor
- Documented left atrial thrombus or another abnormality which precludes catheter introduction
- Left atrial diameter \> 60 mm (parasternal view)
- Hypertrophic cardiomyopathy defined by a left ventricular septum thickness \> 1.5 cm
- Pregnant, parturient or nursing women
- Unable or unwilling to provide written informed consent
- Patient detained by judicial or administrative order
- 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)
Who the study is looking for
- Age \> 18 years of both genders
- Suitable candidate for catheter non-emergent mapping and ablation of atrial fibrillation defined as:
- History of symptomatic persistent atrial fibrillation in the past year documented by ECG AND
- Treatment failure by at least one class of anti-arrhythmic medications (I-IV) (intolerance or recurrence of symptomatic AF)
- 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 (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bordeaux University Hospital Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.