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

AZ Sint-Jan AV

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: ALINE only; Procedure: ALINE + VoM infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04124328

2515

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

ALINE only group

Active Comparator group

Description:

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

Treatment:

Procedure: ALINE only

VoM group

Active Comparator group

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

Treatment:

Procedure: ALINE + VoM infusion