Added Value of Vein of Marshal Ethanol Infusion Compared... | NCT04529785

Studies
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

Sponsor

AZ Sint-Jan AV

Status

Recruiting

Last Update Posted

May 12, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Paroxysmal Atrial Fibrillation

Interventions

SVC only
SVC isolation with substrate modification and vein of Marshal ethanol infusion

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2020Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 20, 2020

First Submission Date that Met QC Criteria

Aug 24, 2020

First Posted Date

Aug 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2026

Last Update Posted Date

May 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SVC only	Procedure	Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone	SVC only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Total procedural time	Comparison of the procedural time between groups	During procedure
Fluoroscopy time	Comparison of the fluoroscopy time between groups

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms