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 Pulmonary Vein Isolation
Led by AZ Sint-Jan AV · Updated on 2026-05-12
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with paroxysmal atrial fibrillation (PAF) who experience recurrence despite durable pulmonary vein isolation (PVI). The study aims to compare the rate of atrial tachyarrhythmia recurrence one year after repeat ablation procedures that either isolate the superior vena cava (SVC) alone or combine SVC isolation with additional substrate modification including vein of Marshal ethanol infusion. This study focuses on improving long-term outcomes for patients undergoing redo ablation for recurrent PAF. Participants are randomly assigned to one of two groups. One group receives radiofrequency (RF) ablation with isolation of the SVC alone. The other group receives RF ablation with isolation of the SVC plus substrate modification and vein of Marshal ethanol infusion. Both procedures are performed during the repeat ablation session. The study evaluates these two approaches to identify potential benefits of adding the vein of Marshal ethanol infusion. During the study, participants are monitored for recurrence of atrial tachyarrhythmia one year after their ablation. Safety is also assessed during the procedure by tracking complications. Additional measures include total procedural time, fluoroscopy time, and RF ablation time. Participants will undergo preprocedural imaging to confirm lasting pulmonary vein isolation. The study duration extends through follow-up assessments for up to one year to evaluate outcomes and safety.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Scheduled for a repeat ablation of paroxysmal atrial fibrillation after previous pulmonary vein isolation
- Confirmation of lasting pulmonary vein isolation at the time of randomization
You will not qualify if you...
- Persistent atrial fibrillation
- Previous ablation with isolation of the superior vena cava, roofline, mitral line, or previous vein of Marshal ethanol infusion
- Left atrial thrombus detected by preprocedural imaging
- Left ventricular ejection fraction less than 35%
- Cardiac surgery within the previous 90 days
- Expecting cardiac transplantation or other cardiac surgery within 180 days
- Coronary angioplasty or stenting within the previous 90 days or myocardial infarction within the previous 60 days
- Documented 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 would preclude enrollment
- Women who are pregnant or planning pregnancy 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
- Condition that prevents vascular access
- International Normalized Ratio greater than 3.5 within 24 hours of procedure for patients on warfarin
- Unable to stop antiarrhythmic drugs for reasons other than atrial fibrillation
- Unwilling or unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During procedure
Participants undergo a repeat ablation procedure for recurrent paroxysmal atrial fibrillation. Depending on group assignment, this includes superior vena cava (SVC) isolation alone or SVC isolation with substrate modification and vein of Marshal ethanol infusion.
1 procedure visit (in-person)
Duration - 1 year
Participants are monitored for recurrence of atrial tachyarrhythmia and safety complications for up to 1 year after the ablation procedure.
Periodic follow-up visits for up to 1 year
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here