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

Syncope Clinical Trial

— SALT-TILT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356207
• Other study ID #: 113-2023
• Status: Recruiting
• Start date: March 20, 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliera di Bolzano
• Contact: Matthias Unterhuber, Dr. Dr.
• Phone: 0471 43 9950
• Email: matthias.unterhuber[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asystole
• Heart Arrest
• Neurally Mediated Syncope
• Pacemaker
• Syncope
• Syncope, Vasovagal

Intervention

Diagnostic Test:
• Tilt 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.

Locations

Country	Name	City	State
Italy	Azienda Sanitaria di Bolzano	Bolzano

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Bolzano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence of syncope	• Recurrence of syncope in patients treated with different pacemaker configurations (DDD-CLS, DDD-RDR, DDDrr) and Neurocardioablation	From enrollment to treatment end 24 months
Secondary	Recurrence of syncope	• Recurrences of syncope in treated patients selected by CSM or loop recorder and negative or positive vasodepressive VTTT	24 months