NCT04529785Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 Aug 2020
- Start date
- 11 Sept 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- AZ Sint-Jan AV
- Diseases
- Atrial fibrillation
- NCT number
- NCT04529785
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 11 Sept 2020 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
- Cardiac surgery within the previous 90 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.
- Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
Other illness
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- Acute illness or active infection at time of index procedure
- Advanced renal insufficiency
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Presence of a condition that precludes vascular access.
Lab values
- Left ventricular ejection fraction \<35%.
Other
- Patients with persistent atrial fibrillation
- Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
- Diagnosed atrial myxoma.
- 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.
- Contraindication to anticoagulation.
- Life expectancy less than 1 year.
- International Normalized Ratio greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
- Unwilling or unable to provide informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint-Jan Brugge-Oostende AV Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.