Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation

Last updated: January 29, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Atrial Fibrillation

Treatment

Pulmonary veins isolation

Destruction of Marshall bundles

Linear ablation in the left and right atria

Clinical Study ID

NCT04681872
CHUBX 2019/55
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 byECG,

  • Patient affiliated or beneficiary of social security scheme,

  • Free, informed and written consent signed by the participant and the principalinvestigator (at least at the inclusion date and before all exams required for theclinical research),

  • Effective contraception for women of childbearing potential.

Exclusion

Exclusion Criteria:

  • Prior left atrial heart ablation procedure,

  • Documented left atrial thrombus or another abnormality which precludes catheterintroduction,

  • Contraindication to anticoagulation therapy (heparin, warfarin, or novel oralanticoagulant (NOAC)),

  • Contraindication to iodinated contrast products (history of major immediatereaction, 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 ablationrisk,

  • 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).

Study Design

Total Participants: 262
Treatment Group(s): 3
Primary Treatment: Pulmonary veins isolation
Phase:
Study Start date:
September 20, 2021
Estimated Completion Date:
September 20, 2027

Study Description

Atrial fibrillation (AF) characterized by a fast and anarchic electrical activation of the atria, results in uncoordinated and inefficient atrial contractions that increases the risks of heart failure and strokes. Besides being a major source of morbidity and mortality, AF is one of the most common heart condition and its prevalence increases with age. Radiofrequency catheter ablation of AF has become one of the treatment of choice in AF resistant to conventional antiarrhythmic drugs. For paroxysmal AF, the ablation strategy is clear and consists in complete pulmonary veins isolation (PVI). However, if this strategy works well in paroxysmal AF, the recurrences rate remains high in persistent AF. Beyond PVI, the ablation strategy that has prevailed over the past two decades remains controversial: the left atrium partition using linear lesions ("cox-maze" strategy); the mapping of the left atrium in AF to identify and localize the arrhythmia sources. Both methods have, besides favoring atrial flutters, failed to demonstrated superiority compared to PVI alone (as showed by the clinical trial STAR AF 2). The investigators aims to test a new method of ablation for patients suffering from persistent AF in order to decrease post ablation recurrence. They propose a strategy targeting the native structures facilitating reentries including the ligament of Marshall (LOM), an embryological remnant. Indeed, two studies have demonstrated that LOM could be the source of focal activities, the substrate of reentries and a strong parasympathetic modulator. For these reasons, LOM may represent a major target in AF treatment besides PV isolation. To date, ablation techniques do not ensure the complete destruction of the Marshall's musculature and parasympathetic ganglia that surround it, largely isolated by a sheath of adipose tissue. To overcome this technical limitation, LOM elimination can be achieved by alcohol injection into the vein of Marshall. This innovative approach will then consist in 3 consecutive steps: 1) the destruction of Marshall bundles by ethanol infusion followed by the ablation of the distal and proximal muscular ramification (coronary sinus and ridge); 2) the standard PV isolation; 3) the linear lesions: the mitral, the roof and of the cavo-tricuspid isthmus, main causes of recurrence in atrial flutter.

Connect with a study center

  • AZ Sint Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • Clinique Saint Augustin

    Bordeaux, 33074
    France

    Site Not Available

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Ambroise Paré Hospital

    Neuilly-sur-Seine, 92200
    France

    Active - Recruiting

  • Les Franciscaines Hospital

    Nîmes, 30032
    France

    Active - Recruiting

  • Bordeaux University Hospital

    Pessac, 33604
    France

    Active - Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 93200
    France

    Active - Recruiting

  • Clinique Pasteur

    Toulouse, 31076
    France

    Active - Recruiting

  • Toulouse University Hospirtal

    Toulouse, 31400
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.