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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: ALINE only; Procedure: ALINE + VoM infusion

• Registration Number: NCT04124328
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2019-10-15
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALINE only group	ALINE only	Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria
VoM group	ALINE + VoM infusion	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

Primary Outcome Measures

Name	Time	Method
Procedural succes rate	At time of ablation	Mitral isthmus block rate after one pass of the mitral line

Secondary Outcome Measures

Name	Time	Method
Total procedure time	At time of ablation
Fluoroscopy time	At time of ablation
Total RF ablation time	At time of ablation
Total extent of ablated LA tissue	At time of ablation
Cardiovascular-related hospitalizations	From time of ablation to one month post procedure
Incidence of atrial flutter	From time of ablation to one month post procedure
Changes in quality of life (SF36)	From inclusion to one month post procedure

Trial Locations

Locations (1)

AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Brugge, Belgium