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

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.

Study Overview

• Status: Recruiting
• Conditions: Syncope; Asystole; Pacemaker; Neurally Mediated Syncope
• Intervention / Treatment: Diagnostic test: Tilt Table Test

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.

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Matthias Unterhuber, Dr. Dr.; Phone Number: 0471 43 9950; Email: matthias.unterhuber@gmail.com
• Study Contact Backup: Name: Marco Tomaino, Dr.; Phone Number: 0471 43 9950; Email: marco.tomaino@sabes.it

Study Locations

• Italy
  • Bolzano, Italy, 39100
    • Recruiting
    • Azienda Sanitaria di Bolzano
    • Contact: Marco Tomaino, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients affected by neurally mediated syncope eligible for invasive treatment according to the ESC Guidelines for pacing 2021

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients affected by neuronally mediated syncope

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recurrence of syncope	• Recurrences of syncope in treated patients selected by CSM or loop recorder and negative or positive vasodepressive VTTT	24 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Bolzano

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Tilt Table Test; Syncope; Pacemaker; Asystole; SALT; Syncope-Asystole Latency Time
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Heart Arrest; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: 113-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No