Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT04681872
Active, not recruiting Not applicable

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

NCT04681872 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Bordeaux
Phase
Not applicable
Started
2021-09-20
Last updated
2025-07-01

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Destruction of Marshall bundlesPulmonary veins isolationLinear ablation in the left and right atria

Destruction of Marshall bundles: Destruction of Marshall bundles by ethanol 96% infusion (2 separate injections of 5ml on 1 minute each) followed by ablation of the distal coronary sinus bundles, the ridge and the saddle.

Pulmonary veins isolation: Achievement of a wide disconnection of the right and left pulmonary veins.

Linear ablation in the left and right atria: Ablation of the mitral, the roof, and the cavo-tricuspid isthmus

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Recurrence of AF or Atrial Tachycardia (AT) greater than 30 seconds with or without antiarrhythmic medications after a single ablation procedure — 2 years
    Recurrence rate (percentage) of AF or AT \> 30 seconds after the blanking period of 3-months post ablation, at 2 years with or without antiarrhythmic medications after a single ablation procedure. Recurrences will be identified through transtelephonic electrocardiogram (ECG) monitor with weekly transmitted ECG and at any time in case of symptoms.

Trial sites (9)

FacilityCityRegionStatus
AZ Sint Jan Brugge Bruges Belgium
Clinique Saint Augustin Bordeaux France
Clermont-Ferrand University Hospital Clermont-Ferrand France
Ambroise Paré Hospital Neuilly-sur-Seine France
Les Franciscaines Hospital Nîmes France
Bordeaux University Hospital Pessac France
Centre Cardiologique du Nord Saint-Denis France
Clinique Pasteur Toulouse France
Toulouse University Hospirtal Toulouse France

More University Hospital, Bordeaux trials in France

Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE) Recruiting
SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older Recruiting
Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia Starting soon
Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus Starting soon
Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology Active, not recruiting

Other trials for the same condition

Modified Left Atrial Maze Procedure for Concomitant AF Ablation Enrolling by invitation
Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation. Recruiting
Contribution of Computed Tomography and Cardiac-MRI in Atrial Fibrillation Ablation Recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04681872 on ClinicalTrials.gov ↗ ← All trials in France