Evaluating the timing of syncope and asystole during tilt table testing
NeuroArrhythmias Area Registry of AIAC (NAARA) Syncope-Asystole Latency Time in Tilt Table Test (SALT-TILT) Study
This study is testing if the timing of fainting during a tilt table test can help predict how well a pacemaker will work for people with reflex syncope.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Bolzano Academic / other |
| Locations | 1 site (Bolzano) |
| Trial ID | NCT06356207 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the timing of loss of consciousness and the onset of asystole during a tilt table test in patients with reflex syncope. It aims to determine if the latency time can predict the effectiveness of pacemaker therapy in preventing syncope recurrences. The study will follow patients for two years and utilize a registry to collect data on their responses to invasive treatments. The hypothesis is that a vasodepressive component may hinder the efficacy of pacing, leading to continued syncope despite a stable heart rhythm.
Who should consider this trial
Good fit: Ideal candidates are patients eligible for invasive treatment of reflex syncope according to established guidelines.
Not a fit: Patients with syncope caused by conditions other than reflex syncope or those with structural heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the selection criteria for pacemaker implantation, potentially reducing syncope recurrences in patients.
How similar studies have performed: While the approach of evaluating syncope timing is novel, similar studies have shown promise in understanding syncope mechanisms and improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bolzano
- Azienda Sanitaria di Bolzano — Bolzano, Italy (Recruiting)
Study contacts
- Study coordinator: Matthias Unterhuber, Dr. Dr.
- Email: matthias.unterhuber@gmail.com
- Phone: 0471 43 9950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.