Paroxysmal Atrial FibrillationVEIN-AFNCT04529785
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
A study testing SVC only and SVC isolation with substrate modification and vein of Marshal ethanol infusion in people with Paroxysmal Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- SVC only and SVC isolation with substrate modification and vein of Marshal ethanol infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Sep 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint-Jan Brugge-Oostende AV
Bruges, Please Select, 8000
Michelle Lycke, MSc, PhD, 00 32 45 32 93, michelle.lycke@azsintjan.be
About this study
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 Pulmonary Vein 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
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- SVC only, SVC isolation with substrate modification and vein of Marshal ethanol infusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVC onlyProcedure or surgery
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 infusionProcedure or surgery
Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion
| Study group | Role | What they receive |
|---|---|---|
| SVC only | Active comparator | Patients in Group 1 will receive an SVC isolation only Receives: Procedure: SVC only |
| SVC isolation with substrate modification and VoM inf | Active comparator | Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion Receives: Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups
Measured: 1 year
Safety (complications)
Comparison of the number of procedural complications between groups
Measured: During procedure
Secondary outcomes (3)
Total procedural time
Comparison of the procedural time between groups
Measured: During procedure
Fluoroscopy time
Comparison of the fluoroscopy time between groups
Measured: During procedure
RF ablation time
Comparison of the radiofrequency time between groups
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start11 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Knecht, AZ Sint-Jan AV
- Investigators
- Sébastien Knecht, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529785
- Sponsor's protocol ID
- 2700
- Acronym
- VEIN-AF
- Status last verified
- May 2026
- First submitted
- 20 Aug 2020
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT04529785
- Acronym / sponsor ID
- VEIN-AF / 2700
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVC only | Active comparator | Procedure: SVC onlyPatients in Group 1 will receive an SVC isolation only |
| SVC isolation with substrate modification and VoM inf | Active comparator | Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusionPatients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVC onlyPatients allocated to this arm will receive an RF ablation with the isolation of the SVC alone | Procedure or surgery | SVC only |
| SVC isolation with substrate modification and vein of Marshal ethanol infusionPatients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion | Procedure or surgery | SVC isolation with substrate modification and VoM inf |
Primary outcome
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
Safety (complications)
Time frame: During procedure
Comparison of the number of procedural complications between groups
3 secondary outcomes
Total procedural time
Time frame: During procedure
Fluoroscopy time
Time frame: During procedure
RF ablation time
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sébastien Knecht, MD, PhD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SVC only and SVC isolation with substrate modification and vein of Marshal ethanol infusion in people with Paroxysmal Atrial Fibrillation, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Lycke, MSc, PhD (+32 50 45 32 93, michelle.lycke@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial tachyarrhythmia 1 year after the index ablation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.