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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 (VEIN-AF)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SVC only
SVC isolation with substrate modification and vein of Marshal ethanol infusion
Sponsored by
AZ Sint-Jan AV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AZ Sint-Jan Brugge-Oostende AVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SVC only

SVC isolation with substrate modification and VoM inf

Arm Description

Patients in Group 1 will receive an SVC isolation only

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

Outcomes

Primary Outcome Measures

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
Safety (complications)
Comparison of the number of procedural complications between groups

Secondary Outcome Measures

Total procedural time
Comparison of the procedural time between groups
Fluoroscopy time
Comparison of the fluoroscopy time between groups
RF ablation time
Comparison of the radiofrequency time between groups

Full Information

First Posted
August 20, 2020
Last Updated
August 2, 2022
Sponsor
AZ Sint-Jan AV
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1. Study Identification

Unique Protocol Identification Number
NCT04529785
Brief 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 PV Isolation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SVC only
Arm Type
Active Comparator
Arm Description
Patients in Group 1 will receive an SVC isolation only
Arm Title
SVC isolation with substrate modification and VoM inf
Arm Type
Active Comparator
Arm Description
Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion
Intervention Type
Procedure
Intervention Name(s)
SVC only
Intervention Description
Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone
Intervention Type
Procedure
Intervention Name(s)
SVC isolation with substrate modification and vein of Marshal ethanol infusion
Intervention Description
Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion
Primary Outcome Measure Information:
Title
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Description
Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups
Time Frame
1 year
Title
Safety (complications)
Description
Comparison of the number of procedural complications between groups
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Total procedural time
Description
Comparison of the procedural time between groups
Time Frame
During procedure
Title
Fluoroscopy time
Description
Comparison of the fluoroscopy time between groups
Time Frame
During procedure
Title
RF ablation time
Description
Comparison of the radiofrequency time between groups
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Lycke, MSc, PhD
Phone
+32 50 45 32 93
Email
michelle.lycke@azsintjan.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Knecht, MD, PhD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
State/Province
Please Select
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Lycke, MSc, PhD
Phone
00 32 45 32 93
Email
michelle.lycke@azsintjan.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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