Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Centre, Poland

About this trial

The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity \>7.5ms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Paroxysmal atrial fibrillation documented in ECG or Holter monitoring

Deceleration capacity >7.5ms

Life expectancy more than 1 year

Age ≥18 years

Disqualifiers

Permanent AF lasting more than one year or persistent AF lasting more than 7 days

AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes

Anteroposterior dimension of the left atrium in the echocardiography ≥43mm

Clinically significant arrhythmias other than AF

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cardioneuroablation of right anterior ganglionated plexus

    Procedure/Surgery

    Right anterior ganglionated plexus will be localized using anatomical approach. Radiofrequency energy will be delivered until heart rate acceleration \>30% is achieved or if radiofrequency time exceeds 120 seconds.

  • Pulmonary vein isolation

    Procedure/Surgery

    Application sites near the ostia of pulmonary veins will be determined. Radiofrequency energy will be delivered using point-by-point technique. After applications, the acute PVI endpoint will be confirmed by the elimination of PV potentials and lack of capture during pacing from the ablation lines.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Cardioneuroablation of right anterior ganglionated plexusExperimental treatment 1 intervention
Group B: Pulmonary vein isolationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

AF recurrence

AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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