Actively Recruiting
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
Led by AZ Sint-Jan AV · Updated on 2026-05-12
100
Participants Needed
1
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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 PV Isolation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients scheduled for a repeat ablation of paroxysmal atrial fibrillation after a previous pulmonary vein isolation
- Confirmation of lasting pulmonary vein isolation at the time of randomization
You will not qualify if you...
- Patients with persistent atrial fibrillation
- Previous ablation with isolation of the superior vena cava, roofline, mitral line, or previous vein of Marshal ethanol infusion
- Presence of left atrial thrombus confirmed by imaging
- Left ventricular ejection fraction less than 35%
- Cardiac surgery within the previous 90 days
- Expected cardiac transplantation or other cardiac surgery within 180 days
- Coronary angioplasty, stenting within the previous 90 days, or myocardial infarction within the previous 60 days
- History of 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 other medical problem precluding enrollment
- Women who are pregnant or plan to become pregnant during the study
- Acute illness or active infection at the 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
- Condition preventing vascular access
- International Normalized Ratio greater than 3.5 within 24 hours of procedure for patients on warfarin
- Patient cannot stop antiarrhythmic drugs for reasons other than atrial fibrillation
- Unwilling or unable to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
AZ Sint-Jan Brugge-Oostende AV
Bruges, Please Select, Belgium, 8000
Actively Recruiting
Research Team
M
Michelle Lycke, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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