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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Tilt Table Test
Diagnostic testThe 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
Trial outcomes
Primary outcomes
SALT (Syncope-Asystole Latency Time)
• Syncope to asystole latency time (SALT) and its prognostic value regarding freedom of syncope recurrence after pacemaker implantation
Secondary outcomes
Recurrence of syncope
• Recurrence of syncope in patients treated with different pacemaker configurations (DDD-CLS, DDD-RDR, DDDrr) and Neurocardioablation
Recurrence of syncope
• Recurrences of syncope in treated patients selected by CSM or loop recorder and negative or positive vasodepressive VTTT
Sponsors and contacts
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