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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06356207
Acronym
SALT-TILT
Enrollment
64
Registered
2024-04-10
Start date
2024-03-20
Completion date
2027-03-31
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope, Pacemaker, Asystole, Neurally Mediated Syncope

Keywords

Syncope, Pacemaker, Tilt Table Test, Asystole, SALT, Syncope-Asystole Latency Time

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTTilt Table 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.

Sponsors

Azienda Ospedaliera di Bolzano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SALT (Syncope-Asystole Latency Time)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

MeasureTime frameDescription
Recurrence of syncopeFrom enrollment to treatment end 24 months• Recurrence of syncope in patients treated with different pacemaker configurations (DDD-CLS, DDD-RDR, DDDrr) and Neurocardioablation

Countries

Italy

Contacts

Primary ContactMatthias Unterhuber, Dr. Dr.
matthias.unterhuber@gmail.com0471 43 9950
Backup ContactMarco Tomaino, Dr.
marco.tomaino@sabes.it0471 43 9950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026