Multicentre, prospective, double blinded, randomized study designed as an intrapatient
      comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on
      prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up
      tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory
      vasovagal syncope.

The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

Syncope, Vasovagal, Neurally-Mediated

A total of 30 patients with refractory cardioinhibitory vasovagal syncope receiving a
      Biotronik pacemaker with Closed-loop Stimulation (CLS) algorithm will be enrolled in the
      study. Two head-up tilt test (HUTT), one during DDD 60/min pacing with CLS algorith turned
      off (CLS-OFF) and the other during DDD-CLS pacing (CLS-ON), will be performed one week apart;
      patients will be randomly and blindly assigned to group A (n=15, first HUTT in CLS-ON mode)
      or B (n=15, first HUTT in CLS-OFF mode). During HUTT heart rate, blood pressure, and the
      incidence of clinical prodromes and syncope wil be recorded.

Closed-loop Stimulation on first

Closed-loop Stimulation off first

Effects of Closed-loop Stimulation vs. DDD Pacing on Prevalence and Timing of Haemodynamic Variations and Clinical Prodromes Induced by Head-up Tilt Test in Patients With Refractory Cardioinhibitory Vasovagal Syncope. The TIRECS Study

The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

About this trial

Study ID

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Phase

Placebo

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Trial Timing

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