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

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Marshall ethanolisation

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolization, Ligament of Marshall, Vein of Marshall

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Marshall ethanolisation with specific catheter

Arm Description

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

Outcomes

Primary Outcome Measures

Acute success rate of the procedure

Success rate complete realization of ethanolization procedure

Secondary Outcome Measures

Total duration of ethanolization procedure

Time between the entry and the removal of the catheter

Time to visualization of Vein of Marshall

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

Duration of balloon positioning

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

Total X Ray duration and radiation dose

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

Incidence of Vein of Marshall dissection

Rate of Vein of Marshall dissection

Incidence of periprocedural complications related to ethanolization

Number and rate of adverse events related to ethanolization

Incidence of complications related to catheter

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

Full Information

NCT ID

NCT05427435

First Posted

June 16, 2022

Last Updated

June 16, 2022

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT05427435

Brief Title

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

Acronym

Innov Marshall

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 9, 2022 (Actual)

Primary Completion Date

May 16, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective single arm monocentric evaluation study

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Marshall ethanolisation with specific catheter

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Marshall ethanolisation

Intervention Description

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

Primary Outcome Measure Information:

Title

Acute success rate of the procedure

Description

Success rate complete realization of ethanolization procedure

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Total duration of ethanolization procedure

Description

Time between the entry and the removal of the catheter

Time Frame

12 months

Title

Time to visualization of Vein of Marshall

Description

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

Time Frame

12 months

Title

Duration of balloon positioning

Description

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

Time Frame

12 months

Title

Total X Ray duration and radiation dose

Description

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

Time Frame

12 months

Title

Incidence of Vein of Marshall dissection

Description

Rate of Vein of Marshall dissection

Time Frame

12 months

Title

Incidence of periprocedural complications related to ethanolization

Description

Number and rate of adverse events related to ethanolization

Time Frame

12 months

Title

Incidence of complications related to catheter

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas MD DERVAL

Phone

(0)5 57 65 64 71

Ext

+33

nicolas.derval@chu-bordeaux.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Lorena SANCHEZ BLANCO

Phone

(0)5 57 62 30 91

Ext

+33

lorena.sanchez-blanco@chu-bordeaux.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas MD DERVAL

Organizational Affiliation

Study Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Bordeaux

City

Pessac

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Derval

nicolas.derval@chu-bordeaux.fr

12. IPD Sharing Statement

Learn more about this trial

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

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