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NCT Number: NCT06356207

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy

Location status: Recruiting

Location contact

Marco Tomaino, Dr.

CONTACT

About this study

Syncope is a common leading affection and is responsible for 1-3% of the presentations in emergency departments and up to 3% of inpatient admissions. Syncope poses often a diagnostic and therapeutic challenge for the attending physician and is often misdiagnosed or underdiagnosed. Patients can be treated with pacemaker implantation when the syncope cause is a cardioinhibition with documented asystole during the syncopal event. When accurately selected, patients benefit from pacemaker therapy with a significant reduction of syncope recurrence in the follow up. However, a substantial portion of the patients (approx. 25%) experience recurrence of syncope despite optimal pacemaker therapy. The underlying mechanism is not well understood and object of the current study.

The main target 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 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.

This is a prospective, multi-center observational study with 2 year follow-up of patients. Patients eligible for invasive treatment of reflex syncope are included.

If after guideline-directed implantable loop recorder insertion no cardioinhibition has been recorded, the patient is included automatically in the registry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients eligible for invasive treatment according to the ESC Guidelines for pacing 2021
  • Written informed consent

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. SALT (Syncope-Asystole Latency Time)

    Time frame: From enrollment to end of treatment 2 weeks

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

Secondary outcomes

  1. Recurrence of syncope

    Time frame: From enrollment to treatment end 24 months

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

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Tomaino, Dr.

CONTACT

[email protected]

0471 43 9950

Matthias Unterhuber, Dr. Dr.

CONTACT

[email protected]

0471 43 9950

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Bolzano

Other

Registry information

Official study title

NeuroArrhythmias Area Registry of AIAC (NAARA) Syncope-Asystole Latency Time in Tilt Table Test (SALT-TILT) Study

Acronym: SALT-TILT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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