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

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusion; Procedure: SVC only

• Registration Number: NCT04529785
• Lead Sponsor: AZ Sint-Jan AV

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-28
• Study Start: 2020-09-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SVC isolation with substrate modification and VoM inf	SVC isolation with substrate modification and vein of Marshal ethanol infusion	Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion
SVC only	SVC only	Patients in Group 1 will receive an SVC isolation only

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial tachyarrhythmia 1 year after the index ablation	1 year	Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups
Safety (complications)	During procedure	Comparison of the number of procedural complications between groups

Secondary Outcome Measures

Name	Time	Method
Total procedural time	During procedure	Comparison of the procedural time between groups
Fluoroscopy time	During procedure	Comparison of the fluoroscopy time between groups
RF ablation time	During procedure	Comparison of the radiofrequency time between groups

Trial Locations

Locations (1)

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