NCT05427435

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
13mo left

Started May 2022

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
May 2022May 2027

Study Start

First participant enrolled

May 9, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2027

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

June 16, 2022

Last Update Submit

June 12, 2025

Conditions

Atrial Fibrillation

Keywords

Persistent atrial fibrillationPulmonary vein isolationCatheter ablationEthanolizationLigament of MarshallVein of Marshall

Outcome Measures

Primary Outcomes (1)

  • Acute success rate of the procedure

    Success rate complete realization of ethanolization procedure

    12 months

Secondary Outcomes (7)

  • Total duration of ethanolization procedure

    12 months

  • Time to visualization of Vein of Marshall

    12 months

  • Duration of balloon positioning

    12 months

  • Total X Ray duration and radiation dose

    12 months

  • Incidence of Vein of Marshall dissection

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Marshall ethanolisation with specific catheter

EXPERIMENTAL

Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter

Device: Marshall ethanolisation

Interventions

Marshall ethanolisationDEVICE

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

Marshall ethanolisation with specific catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Effective contraception for women of childbearing potential

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Pessac, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas MD DERVAL

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas MD DERVAL

CONTACT

(0)5 57 65 64 71nicolas.derval@chu-bordeaux.fr

Lorena SANCHEZ BLANCO

CONTACT

(0)5 57 62 30 91lorena.sanchez-blanco@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: prospective single arm monocentric evaluation study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 22, 2022

Study Start

May 9, 2022

Primary Completion (Estimated)

May 16, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations

FR(1)