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

NCT ID: NCT04124328

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2021-03-01

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALINE only group

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

Group Type: ACTIVE_COMPARATOR

ALINE only

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

ALINE + VoM infusion

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

ALINE only

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Sebastien Knecht

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastien Knecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Lucas Brugge

Locations

AZ Sint-Jan Brugge-Oostende AV

Bruges, , Belgium

Countries

Belgium

References

Gillis K, O'Neill L, Wielandts JY, Hilfiker G, Almorad A, Lycke M, El Haddad M, le Polain de Waroux JB, Tavernier R, Duytschaever M, Knecht S. Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation. JACC Clin Electrophysiol. 2022 Mar;8(3):367-376. doi: 10.1016/j.jacep.2021.11.019. Epub 2022 Feb 23.

Reference Type: DERIVED

PMID: 35331432 (View on PubMed)

Other Identifiers

2515

Identifier Type: -

Identifier Source: org_study_id