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New heart procedure aims to stop AFib from coming back

NCT ID NCT04529785

Disease control Sponsor: AZ Sint-Jan AV Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at people with paroxysmal atrial fibrillation (a type of irregular heartbeat) that came back after a previous treatment. It compares two approaches during a repeat procedure: isolating the superior vena cava alone versus also adding ethanol (alcohol) infusion into the vein of Marshal. The goal is to see which method better prevents the irregular heartbeat from returning one year later. About 100 adults will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint-Jan Brugge-Oostende AV

    RECRUITING

    Bruges, Please Select, 8000, Belgium

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