Atrial FibrillationInnov MarshallNCT05427435
Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation
A study testing Marshall ethanolisation in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Marshall ethanolisation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Pessac
Nicolas Derval, nicolas.derval@chu-bordeaux.fr
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Marshall ethanolisation
- Keywords
- Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolization, Ligament of Marshall, Vein of Marshall
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marshall ethanolisationDevice
Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)
| Study group | Role | What they receive |
|---|---|---|
| Marshall ethanolisation with specific catheter | Experimental | Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter Receives: Device: Marshall ethanolisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute success rate of the procedure
Success rate complete realization of ethanolization procedure
Measured: 12 months
Secondary outcomes (7)
Total duration of ethanolization procedure
Time between the entry and the removal of the catheter
Measured: 12 months
Time to visualization of Vein of Marshall
Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall
Measured: 12 months
Duration of balloon positioning
Time from the 1st injection of iodine to the 1st injection of ethanol
Measured: 12 months
Total X Ray duration and radiation dose
Time of exposure to X Ray and total of received radiation dose
Measured: 12 months
Incidence of Vein of Marshall dissection
Rate of Vein of Marshall dissection
Measured: 12 months
Incidence of periprocedural complications related to ethanolization
Number and rate of adverse events related to ethanolization
Measured: 12 months
Incidence of complications related to catheter
Number and rate of adverse events related to the catheter or its procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start9 May 2022
- Primary completion16 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective single arm monocentric evaluation study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MD DERVAL, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427435
- Sponsor's protocol ID
- CHUBX 2021/18
- Acronym
- Innov Marshall
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2022
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05427435
- Acronym / sponsor ID
- Innov Marshall / CHUBX 2021/18
- Conditions
- Atrial Fibrillation
- Keywords
- Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolization, Ligament of Marshall, Vein of Marshall
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective single arm monocentric evaluation study
| Arm | Type | Receives |
|---|---|---|
| Marshall ethanolisation with specific catheter | Experimental | Device: Marshall ethanolisationPatients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Suitable candidate for catheter ablation of atrial fibrillation defined as:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marshall ethanolisationDestruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml) | Device | Marshall ethanolisation with specific catheter |
Primary outcome
Acute success rate of the procedure
Time frame: 12 months
Success rate complete realization of ethanolization procedure
7 secondary outcomes
Total duration of ethanolization procedure
Time frame: 12 months
Time to visualization of Vein of Marshall
Time frame: 12 months
Duration of balloon positioning
Time frame: 12 months
Total X Ray duration and radiation dose
Time frame: 12 months
Incidence of Vein of Marshall dissection
Time frame: 12 months
Incidence of periprocedural complications related to ethanolization
Time frame: 12 months
Incidence of complications related to catheter
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas MD DERVAL principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marshall ethanolisation in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas MD DERVAL ((0)5 57 65 64 71 ext. +33, nicolas.derval@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute success rate of the procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.