Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation

NCT ID: NCT04529785

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2023-08-31

Brief Summary

The superior vena cava (SVC) is one of the most common non pulmonary vein (PV)-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency (RF)-ablation under close monitoring of the phrenic nerve. However, adding substrate modification and vein of Marshal (VoM) ethanol infusion to the ablation procedure might substantially improve long-term outcomes.

The aim of this study is to evaluate the recurrence rate 1 year after the index ablation in patients undergoing a redo ablation for recurrent paroxysmal atrial fibrillation (PAF) despite durable pulmonary vein isolation (PVI) with either SVC isolation alone or with substrate modification including vein of Marshal ethanolisation in addition to SVC isolation alone

Conditions

Paroxysmal Atrial Fibrillation

Study Design

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

Study Groups

SVC only

Patients in Group 1 will receive an SVC isolation only

Group Type: ACTIVE_COMPARATOR

SVC only

Intervention Type: PROCEDURE

Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone

SVC isolation with substrate modification and VoM inf

Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion

Group Type: ACTIVE_COMPARATOR

SVC isolation with substrate modification and vein of Marshal ethanol infusion

Intervention Type: PROCEDURE

Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion

Interventions

SVC only

Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone

Intervention Type: PROCEDURE

SVC isolation with substrate modification and vein of Marshal ethanol infusion

Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients older than 18 years
• Patients scheduled for a repeat ablation of PAF after a previous PVI
• Confirmation of lasting pulmonary vein isolation at the time of randomization

Exclusion Criteria

• Patients with persistent atrial fibrillation
• Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
• Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
• Left ventricular ejection fraction <35%.
• Cardiac surgery within the previous 90 days.
• Expecting cardiac transplantation or other cardiac surgery within 180 days.
• Coronary percutaneous transluminal coronary angioplasty/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
• Advanced renal insufficiency
• Unstable angina.
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation.
• Life expectancy less than 1 year.
• Presence of a condition that precludes vascular access.
• International Normalized Ratio 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

Sébastien Knecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Locations

AZ Sint-Jan Brugge-Oostende AV

Bruges, Please Select, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Michelle Lycke, MSc, PhD

Role: CONTACT

michelle.lycke@azsintjan.be

+32 50 45 32 93

Facility Contacts

Michelle Lycke, MSc, PhD

Role: primary

michelle.lycke@azsintjan.be

00 32 45 32 93

Other Identifiers

2700

Identifier Type: -

Identifier Source: org_study_id