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

Paroxysmal Atrial Fibrillation Clinical Trial

— VEIN-AF  

Official title:

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 Pulmonary Vein Isolation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529785
• Other study ID #: 2700
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2022
• Source: AZ Sint-Jan AV
• Contact: Michelle Lycke, MSc, PhD
• Phone: +32 50 45 32 93
• Email: michelle.lycke[@]azsintjan.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Locations

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

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	Recurrence of atrial tachyarrhythmia 1 year after the index ablation	Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups	1 year
Primary	Safety (complications)	Comparison of the number of procedural complications between groups	During procedure
Secondary	Total procedural time	Comparison of the procedural time between groups	During procedure
Secondary	Fluoroscopy time	Comparison of the fluoroscopy time between groups	During procedure
Secondary	RF ablation time	Comparison of the radiofrequency time between groups	During procedure