Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation (MARSHALINE)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: ALINE only; Procedure: ALINE + VoM infusion

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between the ages of 18 and 85 years
• Diagnosed with symptomatic AF without previous mitral isthmus line ablation

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ALINE only group; Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria	Procedure: ALINE only; In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.
Active Comparator: VoM group; 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	Procedure: ALINE + VoM infusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural succes rate	Mitral isthmus block rate after one pass of the mitral line	At time of ablation

Secondary Outcome Measures

Outcome Measure	Time Frame
Total procedure time	At time of ablation
Fluoroscopy time	At time of ablation
Total RF ablation time	At time of ablation
Total extent of ablated LA tissue	At time of ablation
Cardiovascular-related hospitalizations	From time of ablation to one month post procedure
Changes in quality of life (SF36)	From inclusion to one month post procedure
Incidence of atrial flutter	From time of ablation to one month post procedure

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Sebastien Knecht, MD, PhD, AZ Sint-Jan Brugge-Oostende AV

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No