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NCT Number: NCT05427435

Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation

In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year 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 systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set.

The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Pessac, France

Location status: Recruiting

Location contact

Nicolas Derval

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suitable candidate for catheter ablation of atrial fibrillation defined as:
  • history of symptomatic persistent atrial fibrillation
  • Redo procedure for persistent AF or paroxysmal AF with isolated PV and no history of ethanol infusion in the VOM.
  • Age > 18 years of both genders
  • 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

  • Minor
  • 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 hypersensivity 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
  • 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
  • Pregnant, parturient or nursing women
  • Unable or unwilling to provide written informed consent
  • Patient detained by judicial or administrative order
  • Patient under psychiatric care
  • 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)

Treatment and study plan

Marshall ethanolisation

Device

Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)

Primary outcomes

  1. Acute success rate of the procedure

    Time frame: 12 months

    Success rate complete realization of ethanolization procedure

Secondary outcomes

  1. Total duration of ethanolization procedure

    Time frame: 12 months

    Time between the entry and the removal of the catheter

  2. Time to visualization of Vein of Marshall

    Time frame: 12 months

    Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall

  3. Duration of balloon positioning

    Time frame: 12 months

    Time from the 1st injection of iodine to the 1st injection of ethanol

  4. Total X Ray duration and radiation dose

    Time frame: 12 months

    Time of exposure to X Ray and total of received radiation dose

  5. Incidence of Vein of Marshall dissection

    Time frame: 12 months

    Rate of Vein of Marshall dissection

  6. Incidence of periprocedural complications related to ethanolization

    Time frame: 12 months

    Number and rate of adverse events related to ethanolization

  7. Incidence of complications related to catheter

    Time frame: 12 months

    Number and rate of adverse events related to the catheter or its procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Lorena SANCHEZ BLANCO

CONTACT

[email protected]

(0)5 57 62 30 91 ext. +33

Nicolas MD DERVAL

CONTACT

[email protected]

(0)5 57 65 64 71 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation

Acronym: Innov Marshall

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2022
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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