Skip to main content
OpenTrials
Completed

NCT Number: NCT04124328

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALINE + VoM infusion

Procedure

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 only

Procedure

In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.

Primary outcomes

  1. Procedural succes rate

    Time frame: At time of ablation

    Mitral isthmus block rate after one pass of the mitral line

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation

Acronym: MARSHALINE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.