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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAZ Sint-Jan AV

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SVC only

    Procedure/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 infusion

    Procedure/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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SVC onlyActive comparator 1 intervention
Group B: SVC isolation with substrate modification and VoM infActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year
2

Safety (complications)

Comparison of the number of procedural complications between groups

Time frame
During procedure

Secondary outcomes

1

Total procedural time

Comparison of the procedural time between groups

Time frame
During procedure
2

Fluoroscopy time

Comparison of the fluoroscopy time between groups

Time frame
During procedure
3

RF ablation time

Comparison of the radiofrequency time between groups

Time frame
During procedure

Other outcomes

Sponsors and contacts

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