跳至主要内容
临床试验/NCT06356207
NCT06356207招募中不适用

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

Azienda Ospedaliera di Bolzano1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
SALT (Syncope-Asystole Latency Time)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients eligible for invasive treatment according to the ESC Guidelines for pacing 2021
  • Written informed consent

排除标准

  • 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

结局指标

主要结局

SALT (Syncope-Asystole Latency Time)

时间窗: From enrollment to end of treatment 2 weeks

• Syncope to asystole latency time (SALT) and its prognostic value regarding freedom of syncope recurrence after pacemaker implantation

次要结局

  • Recurrence of syncope(24 months)

研究者

发起方
Azienda Ospedaliera di Bolzano
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Unterhuber

Principal Investigator

Azienda Ospedaliera di Bolzano

研究点 (1)

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