Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera di Bolzano

About this trial

Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients eligible for invasive treatment according to the ESC Guidelines for pacing 2021

Written informed consent

Disqualifiers

Other condition which explains syncope cause other than reflex syncope

Structural heart disease (valvular, ischaemic, cardiomyopathies)

Pregnancy

Patient denial to be recorded on video during tilt table test

Trial population

Patients affected by neurally mediated syncope eligible for invasive treatment according to the ESC Guidelines for pacing 2021

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tilt Table Test

    Diagnostic test

    The main goal of the study is to evaluate the time elapsed between the T-LOC during Video Tilt Table Testing and the asystole at the ECG using a national registry and to assess its predictive value in patients undergoing invasive treatment. The hypothesis is that a vasodepressive component could lessen the effect of pacing in a patient, leading to cerebral hypoperfusion and syncope despite maintaining a stable rhythm.

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Patients affected by neuronally mediated syncope1 intervention

Trial outcomes

Primary outcomes

1

SALT (Syncope-Asystole Latency Time)

• Syncope to asystole latency time (SALT) and its prognostic value regarding freedom of syncope recurrence after pacemaker implantation

Time frame
From enrollment to end of treatment 2 weeks

Secondary outcomes

1

Recurrence of syncope

• Recurrence of syncope in patients treated with different pacemaker configurations (DDD-CLS, DDD-RDR, DDDrr) and Neurocardioablation

Time frame
From enrollment to treatment end 24 months
2

Recurrence of syncope

• Recurrences of syncope in treated patients selected by CSM or loop recorder and negative or positive vasodepressive VTTT

Time frame
24 months

Other outcomes

Sponsors and contacts

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