Health TrialsbyHealthPanel

National Registry of Cardioneuroablation in Recurrent Reflex Syncope

ConditionsSyncope, VasovagalBradycardiaHeart Arrest
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital, Bordeaux

About this trial

This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 or more

Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystolic component (≥3 second pause) recorded during a spontaneous episode. The asystole can be related to sinus arrest or paroxysmal AV block.

Scheduled cardioneuroablation procedure

Estimated residual battery life ≥ 1 year.

Disqualifiers

Contraindication to anticoagulation therapy: major bleeding, risk of major bleeding, severe hepatic disease

Contraindication to cardiac CT: contrast medium allergies

Intracardiac thrombus

Patient detained by judicial or administrative decision.

Trial population

patients with vagally-mediated extrinsic bradycardia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardioneuroablation

    Procedure/Surgery

    radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Cardioneuroablation1 intervention

Trial outcomes

Primary outcomes

1

Recurrence of vasovagal syncope

Number of patients with recurrence

Time frame
12 months

Secondary outcomes

1

Recurrence of vasovagal syncope in different subgroups

Number of patients with recurrence

Time frame
12 months
2

Efficacy of cardioneuroablation procedure

Number of asystolic pauses

Time frame
12 months
3

prevalence of post-ablation pre-syncopal events

Number of post-ablation pre-syncopal events

Time frame
12 months
4

correlation between ablation sites and epicardial fat pads

spatial correlation between ablation sites and epicardial fat pads

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov
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