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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ALINE + VoM infusion
ALINE only
Sponsored by
AZ Sint-Jan AV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

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.

Sites / Locations

  • AZ Sint-Jan Brugge-Oostende AV

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ALINE only group

VoM group

Arm Description

Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria

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

Outcomes

Primary Outcome Measures

Procedural succes rate
Mitral isthmus block rate after one pass of the mitral line

Secondary Outcome Measures

Total procedure time
Fluoroscopy time
Total RF ablation time
Total extent of ablated LA tissue
Cardiovascular-related hospitalizations
Changes in quality of life (SF36)
Incidence of atrial flutter

Full Information

First Posted
October 9, 2019
Last Updated
August 2, 2022
Sponsor
AZ Sint-Jan AV
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1. Study Identification

Unique Protocol Identification Number
NCT04124328
Brief Title
Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
Acronym
MARSHALINE
Official Title
The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALINE only group
Arm Type
Active Comparator
Arm Description
Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria
Arm Title
VoM group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
ALINE + VoM infusion
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ALINE only
Intervention Description
In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.
Primary Outcome Measure Information:
Title
Procedural succes rate
Description
Mitral isthmus block rate after one pass of the mitral line
Time Frame
At time of ablation
Secondary Outcome Measure Information:
Title
Total procedure time
Time Frame
At time of ablation
Title
Fluoroscopy time
Time Frame
At time of ablation
Title
Total RF ablation time
Time Frame
At time of ablation
Title
Total extent of ablated LA tissue
Time Frame
At time of ablation
Title
Cardiovascular-related hospitalizations
Time Frame
From time of ablation to one month post procedure
Title
Changes in quality of life (SF36)
Time Frame
From inclusion to one month post procedure
Title
Incidence of atrial flutter
Time Frame
From time of ablation to one month post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Knecht, MD, PhD
Organizational Affiliation
AZ Sint-Jan Brugge-Oostende AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
35331432
Citation
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.
Results Reference
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Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation

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