MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial

NCT04206982 | Completed DMC

• 1 other identifier: CHUBX 2019/08
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recurrence of AF or AT greater than 30 seconds with or without antiarrhythmic medications.

  Recurrence rate (percentage) of AF or AT \> 30 seconds after the blanking period of 3-months post ablation, at 12 months with or without antiarrhythmic medications. Recurrences will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.

  12 months

Secondary Outcomes (9)

• Recurrence of AF greater than 30 seconds

  12 months

• Recurrence of AF or AT greater than 30 seconds without antiarrhythmic medications

  12 months

• Rate of patients under antiarrhythmic medications

  12 months

• Number of patients with repeat procedures

  12 months

• Rate of periprocedural complications

  12 months

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 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
• Effective contraception for women of childbearing potential

You may not qualify if:

• Minor
• 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 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
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

Related Publications (2)

• Valderrabano M, Chen HR, Sidhu J, Rao L, Ling Y, Khoury DS. Retrograde ethanol infusion in the vein of Marshall: regional left atrial ablation, vagal denervation and feasibility in humans. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):50-6. doi: 10.1161/CIRCEP.108.818427.

  PMID: 19756206 BACKGROUND

• Derval N, Tixier R, Duchateau J, Bouteiller X, Loock T, Denis A, Chauvel R, Bouyer B, Arnaud M, Yokoyama M, Kowalewski C, Monaco C, Ascione C, Sacher F, Hocini M, Jais P, Haissaguerre M, Pambrun T. Marshall-Plan Ablation Strategy Versus Pulmonary Vein Isolation in Persistent AF: A Randomized Controlled Trial. Circ Arrhythm Electrophysiol. 2025 May;18(5):e013427. doi: 10.1161/CIRCEP.124.013427. Epub 2025 May 20.

  PMID: 40392905 DERIVED

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

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, monocentric clinical trial of superiority.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: January 22, 2020
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)