Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study
SALT-TILT
NeuroArrhythmias Area Registry of AIAC (NAARA) Syncope-Asystole Latency Time in Tilt Table Test (SALT-TILT) Study
1 other identifier
observational
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2024
CompletedFirst Submitted
Initial submission to the registry
April 4, 2024
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedApril 11, 2024
April 1, 2024
1.9 years
April 4, 2024
April 10, 2024
Conditions
Keywords
Outcome Measures
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
From enrollment to end of treatment 2 weeks
Secondary Outcomes (2)
Recurrence of syncope
From enrollment to treatment end 24 months
Recurrence of syncope
24 months
Study Arms (1)
Patients affected by neuronally mediated syncope
Interventions
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.
Eligibility Criteria
Patients affected by neurally mediated syncope eligible for invasive treatment according to the ESC Guidelines for pacing 2021
You may qualify if:
- Patients eligible for invasive treatment according to the ESC Guidelines for pacing 2021
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Sanitaria di Bolzano
Bolzano, 39100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 4, 2024
First Posted
April 10, 2024
Study Start
March 20, 2024
Primary Completion
March 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
April 11, 2024
Record last verified: 2024-04