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

Atrial Fibrillation Clinical Trial

— MARSHALINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124328
• Other study ID #: 2515
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural succes rate	Mitral isthmus block rate after one pass of the mitral line	At time of ablation
Secondary	Total procedure time		At time of ablation
Secondary	Fluoroscopy time		At time of ablation
Secondary	Total RF ablation time		At time of ablation
Secondary	Total extent of ablated LA tissue		At time of ablation
Secondary	Cardiovascular-related hospitalizations		From time of ablation to one month post procedure
Secondary	Changes in quality of life (SF36)		From inclusion to one month post procedure
Secondary	Incidence of atrial flutter		From time of ablation to one month post procedure