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

NCT04681872 | Active Not Recruiting DMC

• 1 other identifier: CHUBX 2019/55
• Study Type: interventional
• Target: 262
• Locations: 2 countries
• Sites: 9

Brief 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).

Conditions

Atrial Fibrillation

Keywords

Persistent atrial fibrillation; Pulmonary vein isolation; Catheter ablation; Ethanolization; Ligament of Marshall

Outcome Measures

Primary Outcomes (1)

• Recurrence of AF or Atrial Tachycardia (AT) greater than 30 seconds with or without antiarrhythmic medications after a single ablation procedure

  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.

  2 years

Secondary Outcomes (9)

• Recurrence of AF or AT greater than 30 seconds after multiple ablation procedures

  2 years

• Recurrence of AF or AT greater than 30 seconds after a single ablation procedure (1)

  2 years

• Recurrence of AF greater than 30 seconds after a single ablation procedure (2)

  2 years

• Recurrence of AF greater than 30 seconds after multiple ablation procedure.

  2 years

• Recurrence of AF or AT greater than 30 seconds without antiarrhythmic medications after a single ablation procedure.

  2 years

Study Arms (2)

Marshall Plan arm

EXPERIMENTAL

Patients will undergo (1) the destruction of Marshall bundles by ethanol infusion followed by ablation of the distal coronary sinus bundles, the ridge and the saddle; (2) the standard pulmonary veins sleeves isolation; (3) and finally the ablation of the mitral, the roof, and the cavo-tricuspid isthmus.

Procedure: Destruction of Marshall bundles; Procedure: Pulmonary veins isolation; Procedure: Linear ablation in the left and right atria

Pulmonary vein isolation arm

ACTIVE COMPARATOR

Procedure: Pulmonary veins isolation

Interventions

Destruction of Marshall bundles PROCEDURE

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.

Marshall Plan arm

Pulmonary veins isolation PROCEDURE

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

Marshall Plan arm; Pulmonary vein isolation arm

Linear ablation in the left and right atria PROCEDURE

Ablation of the mitral, the roof, and the cavo-tricuspid isthmus

Marshall Plan arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Effective contraception for women of childbearing potential.

You may not qualify if:

• 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,
• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (9)

AZ Sint Jan Brugge

Bruges, 8000, Belgium

Location

Clinique Saint Augustin

Bordeaux, 33074, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

Ambroise Paré Hospital

Neuilly-sur-Seine, 92200, France

Location

Les Franciscaines Hospital

Nîmes, 30032, France

Location

Bordeaux University Hospital

Pessac, 33604, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Toulouse University Hospirtal

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas DERVAL, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Marshall Plan is a prospective randomized, parallel-group, multicenter clinical trial of superiority

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: September 20, 2021
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

BE (1); FR (8)