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)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    100
  • sponsor
    AZ Sint-Jan AV
Updated on 9 August 2022
atrial fibrillation
fibrillation
paroxysmal atrial fibrillation
pulmonary vein isolation

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

Details
Condition Paroxysmal Atrial Fibrillation
Treatment SVC only, SVC isolation with substrate modification and vein of Marshal ethanol infusion
Clinical Study IdentifierNCT04529785
SponsorAZ Sint-Jan AV
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

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
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