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

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ClinicalTrials.gov Identifier: NCT04124328
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sebastien Knecht, AZ Sint-Jan AV

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: ALINE + VoM infusion Procedure: ALINE only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Procedural succes rate [ Time Frame: At time of ablation ]
    Mitral isthmus block rate after one pass of the mitral line


Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: At time of ablation ]
  2. Fluoroscopy time [ Time Frame: At time of ablation ]
  3. Total RF ablation time [ Time Frame: At time of ablation ]
  4. Total extent of ablated LA tissue [ Time Frame: At time of ablation ]
  5. Cardiovascular-related hospitalizations [ Time Frame: From time of ablation to one month post procedure ]
  6. Changes in quality of life (SF36) [ Time Frame: From inclusion to one month post procedure ]
  7. Incidence of atrial flutter [ Time Frame: From time of ablation to one month post procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124328


Contacts
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Contact: Sebastien Knecht, MD, PhD +32 50 45 26 70 sebastien.knecht@azsintjan.be
Contact: Michelle Lycke, MSc, PhD +32 50 45 32 93 michelle.lycke@azsintjan.be

Locations
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Belgium
AZ Sint-Jan Brugge-Oostende AV Recruiting
Brugge, Belgium, 8000
Contact: Sébastien Knecht, MD, PhD       sebastien.knecht@azsintjan.be   
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Sebastien Knecht, MD, PhD AZ Sint-Jan Brugge Oostende AV
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Responsible Party: Sebastien Knecht, Professor Doctor, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT04124328    
Other Study ID Numbers: 2515
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes