SVC-isolation in Redo-AF Ablation With Isolated PV

ConditionParoxysmal AF
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Medico Teknon

About this trial

Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein isolation"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years.

Confirmed diagnosis of recurrent paroxysmal AF

Previous transcatheter PVI-only procedure for AF.

Evidence of persistently isolated pulmonary veins at repeat procedure.

Disqualifiers

Age < 18 years.

Pregnancy.

Concomitant investigation treatments.

Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empirical superior vena cava isolation

    Procedure/Surgery

    Empirical superior vena cava isolation with radiofrequency ablation

  • Ablation without empirical superior vena cava isolation

    Procedure/Surgery

    No ablation or ablation of other arrhythmic foci wuthout empirical superior vena cava isolation

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SVC isolation groupActive comparator 1 intervention
Group B: Control armSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Arrhythmia-free survival

Occurence of any sustained atrial arrhythmia (AF, atrial flutter or any atrial tachycardia) lasting ≥ 30 s, after a 2-month blanking period

Time frame
12 months follow-up

Secondary outcomes

1

Procedure-related complications

Any procedure complication

Time frame
12 months follow-up

Other outcomes

Sponsors and contacts

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