Atrial FibrillationMARSHALINENCT04124328
Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
A study testing ALINE + VoM infusion and ALINE only in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol. 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?
- ALINE + VoM infusion and ALINE only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients between the ages of 18 and 85 years
- Diagnosed with symptomatic AF without previous mitral isthmus line ablation
Who cannot join
- Previous MI line ablation
- Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc.
- Left ventricular ejection fraction <35%.
- Cardiac surgery within the previous 90 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
Show all 23Show fewer
- Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- Documented history of a thromboembolic event within the previous 90 days.
- Diagnosed atrial myxoma.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- Women who are pregnant or who plan to become pregnant during the study.
- Acute illness or active infection at time of index procedure
- Renal insufficiency
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- Life expectancy less than 1 year.
- Uncontrolled heart failure.
- Presence of a condition that precludes vascular access.
- INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
- Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.
- Conditions
- Atrial Fibrillation
- Being tested
- ALINE + VoM infusion, ALINE only
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALINE + VoM infusionProcedure or surgery
In patients assigned to the ALINE + VoM infusion group, extended ablation will be performed according to the ALINE criteria. Additionally, the vein of Marshall will be infused with ethanol.
ALINE onlyProcedure or surgery
In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.
| Study group | Role | What they receive |
|---|---|---|
| ALINE only group | Active comparator | Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria Receives: Procedure: ALINE only |
| VoM group | Active comparator | Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria and vein of Marshall (VoM) ethanol infusion Receives: Procedure: ALINE + VoM infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural succes rate
Mitral isthmus block rate after one pass of the mitral line
Measured: At time of ablation
Secondary outcomes (7)
Total procedure time
Measured: At time of ablation
Fluoroscopy time
Measured: At time of ablation
Total RF ablation time
Measured: At time of ablation
Total extent of ablated LA tissue
Measured: At time of ablation
Cardiovascular-related hospitalizations
Measured: From time of ablation to one month post procedure
Changes in quality of life (SF36)
Measured: From inclusion to one month post procedure
Incidence of atrial flutter
Measured: From time of ablation to one month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start15 Oct 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Knecht, AZ Sint-Jan AV
- Investigators
- Sebastien Knecht, MD, PhD, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124328
- Sponsor's protocol ID
- 2515
- Acronym
- MARSHALINE
- Status last verified
- Aug 2022
- First submitted
- 9 Oct 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gillis K, O'Neill L, Wielandts JY, Hilfiker G, Almorad A, Lycke M, El Haddad M, le Polain de Waroux JB, Tavernier R, Duytschaever M, Knecht S. Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation. JACC Clin Electrophysiol. 2022 Mar;8(3):367-376. doi: 10.1016/j.jacep.2021.11.019. Epub 2022 Feb 23.
PubMed 35331432
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04124328
- Acronym / sponsor ID
- MARSHALINE / 2515
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Oct 2019 (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 this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALINE only group | Active comparator | Procedure: ALINE onlyPatients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria |
| VoM group | Active comparator | Procedure: ALINE + VoM infusionPatients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria and vein of Marshall (VoM) ethanol infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18 and 85 years
- Diagnosed with symptomatic AF without previous mitral isthmus line ablation
Key exclusion criteria (23 listed)
- Previous MI line ablation
- Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc.
- Left ventricular ejection fraction <35%.
- Cardiac surgery within the previous 90 days.
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 |
|---|---|---|
| ALINE + VoM infusionIn patients assigned to the ALINE + VoM infusion group, extended ablation will be performed according to the ALINE criteria. Additionally, the vein of Marshall will be infused with ethanol. | Procedure or surgery | VoM group |
| ALINE onlyIn patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria. | Procedure or surgery | ALINE only group |
Primary outcome
Procedural succes rate
Time frame: At time of ablation
Mitral isthmus block rate after one pass of the mitral line
7 secondary outcomes
Total procedure time
Time frame: At time of ablation
Fluoroscopy time
Time frame: At time of ablation
Total RF ablation time
Time frame: At time of ablation
Total extent of ablated LA tissue
Time frame: At time of ablation
Cardiovascular-related hospitalizations
Time frame: From time of ablation to one month post procedure
Changes in quality of life (SF36)
Time frame: From inclusion to one month post procedure
Incidence of atrial flutter
Time frame: From time of ablation to one month post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 35331432Gillis K, O'Neill L, Wielandts JY, Hilfiker G, Almorad A, Lycke M, El Haddad M, le Polain de Waroux JB, Tavernier R, Duytschaever M, Knecht S. Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation. JACC Clin Electrophysiol. 2022 Mar;8(3):367-376. doi: 10.1016/j.jacep.2021.11.019. Epub 2022 Feb 23.
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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. This study is not recruiting at the moment.
Sebastien Knecht, MD, PhD principal investigator
AZ Sint-Lucas Brugge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALINE + VoM infusion and ALINE only in people with Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
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 2 inclusion and 23 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: finished, as of the sponsor's last update on 3 Aug 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural succes rate (time frame: At time of ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124328, which also lists 1 linked publication.
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 3 Aug 2022.