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

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

This test will see if adding vein of Marshall ethanol infusion and substrate modification to superior vena cava isolation helps adults having a repeat ablation for recurrent paroxysmal atrial fibrillation despite durable pulmonary vein isolation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AZ Sint-Jan AV (other)
• Locations: 1 site (Bruges, Please Select)
• Trial ID: NCT04529785 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with recurrent paroxysmal atrial fibrillation scheduled for a repeat ablation who have confirmed durable pulmonary vein isolation at the time of the procedure are ideal candidates.

Not a fit: Patients with persistent AF, prior SVC isolation or prior VoM ethanol infusion, significant left ventricular dysfunction (LVEF <35%), left atrial thrombus, recent major cardiac surgery or recent MI are unlikely to be eligible or to gain benefit from this approach.

Why it matters

Potential benefit: If successful, the addition of VoM ethanol infusion could lower one-year AF recurrence and reduce the need for further ablation procedures.

How similar studies have performed: Small trials and observational series of vein of Marshall ethanol infusion have suggested benefit in reducing arrhythmia recurrence, but randomized evidence in this specific redo paroxysmal AF setting is limited.

Eligibility criteria

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 this trial is running

Bruges, Please Select

• 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

Conditions: Paroxysmal Atrial Fibrillation