Adding vein of Marshall ethanol infusion to superior vena cava isolation for repeat ablation of recurrent paroxysmal atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with recurrent paroxysmal atrial fibrillation who have durable pulmonary vein isolation and are scheduled for a redo ablation will be randomized to receive either superior vena cava (SVC) isolation alone or SVC isolation plus substrate modification including vein of Marshall (VoM) ethanol infusion. SVC isolation is performed using circular radiofrequency ablation with phrenic nerve monitoring, and VoM ethanol infusion targets epicardial connections thought to sustain arrhythmia. Patients will be followed for one year after the index procedure to measure arrhythmia recurrence. The primary outcome is the rate of AF recurrence at 12 months after the repeat ablation.

Why it matters

Who can join: the full rules

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.

Where it's running

• AZ Sint-Jan Brugge-Oostende AV
  Bruges, Please Select, Belgium Recruiting

Study contacts

• Principal investigator: Sébastien Knecht, MD, PhD — AZ Sint-Jan AV
• Study coordinator: Michelle Lycke, MSc, PhD
• Email: michelle.lycke@azsintjan.be
• Phone: +32 50 45 32 93

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Conscious Sedation vs General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

  This trial tests whether local anesthesia with conscious sedation can match general anesthesia for pulsed field ablation in adults with paroxysmal atrial fibrillation.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07877519

• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

  This registry will test how well Boston Scientific pulsed field ablation works and how safe it is for Black, Hispanic, Asian, and other underrepresented adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 2 sites Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT07535268

• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

  This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• Factors that affect atrial tracking and atrial fibrillation in people receiving the Micra AV2 pacemaker

  This will see how well the Micra AV2 device tracks atrial activity and how often short episodes of paroxysmal atrial fibrillation occur in adults who receive the device.

  Recruiting Northwell Health · New Hyde Park, New York · NCT07344961

• Burst stimulation with pulmonary vein and superior vena cava isolation for paroxysmal atrial fibrillation

  This will try burst electrical stimulation together with pulmonary vein and superior vena cava isolation to lower the chance that paroxysmal atrial fibrillation comes back after a first catheter ablation in adults.

  Recruiting at 3 sites Zhongnan Hospital · Wuhan, Hubei and 2 other locations · NCT07281898

• Arrhythmia mapping with a paddle-shaped multi-electrode catheter

  This test uses a new high-density multi-electrode catheter to see if it can safely map atrial and ventricular arrhythmias in adults having catheter mapping and ablation.

  Recruiting at 5 sites Biosense Webster, Inc. · Bruges and 4 other locations · NCT07116525

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.