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NCT Number: NCT04529785

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan Brugge-Oostende AV

Bruges, Please Select, 8000, Belgium

Location status: Recruiting

Location contact

Michelle Lycke, MSc, PhD

CONTACT

[email protected]

00 32 45 32 93

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SVC only

Procedure

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

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

Primary outcomes

  1. Recurrence of atrial tachyarrhythmia 1 year after the index ablation

    Time frame: 1 year

    Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups

  2. Safety (complications)

    Time frame: During procedure

    Comparison of the number of procedural complications between groups

Secondary outcomes

  1. Total procedural time

    Time frame: During procedure

    Comparison of the procedural time between groups

  2. Fluoroscopy time

    Time frame: During procedure

    Comparison of the fluoroscopy time between groups

  3. RF ablation time

    Time frame: During procedure

    Comparison of the radiofrequency time between groups

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Lycke, MSc, PhD

CONTACT

[email protected]

+32 50 45 32 93

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study 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

Acronym: VEIN-AF

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2020
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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