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

NCT04529785 | Recruiting

• 1 other identifier: 2700
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• Safety (complications)

  Comparison of the number of procedural complications between groups

  During procedure

Secondary Outcomes (3)

• Total procedural time

  During procedure

• Fluoroscopy time

  During procedure

• RF ablation time

  During procedure

Study Arms (2)

SVC only

ACTIVE COMPARATOR

Patients in Group 1 will receive an SVC isolation only

Procedure: SVC only

SVC isolation with substrate modification and VoM inf

ACTIVE COMPARATOR

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

Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusion

Interventions

SVC only PROCEDURE

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

SVC only

SVC isolation with substrate modification and vein of Marshal ethanol infusion 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

SVC isolation with substrate modification and VoM inf

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

AZ Sint-Jan Brugge-Oostende AV

Bruges, Please Select, 8000, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Knecht, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Lycke, MSc, PhD

CONTACT

+32 50 45 32 93; michelle.lycke@azsintjan.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 28, 2020
• Study Start: September 11, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)