Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356207
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-04
Brief Title:
Syncope-Asystole Latency Time in Tilt Table Test The SALT-TILT Study
Sponsor:
Azienda Ospedaliera di Bolzano
Organization:
Azienda Ospedaliera di Bolzano
Study Overview
Official Title:
NeuroArrhythmias Area Registry of AIAC NAARA Syncope-Asystole Latency Time in Tilt Table Test SALT-TILT Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SALT-TILT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None