NCT02573649

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Azienda Ospedaliera Cardinale G. Panico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Syncope, Vasovagal, Neurally-Mediated

Interventions

Type	Name	Description
DEVICE	Closed-loop Stimulation on first	Closed-loop Stimulation algorithm is turned on in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned off and the patient performs a second head up tilt test.
DEVICE	Closed-loop Stimulation off first	Closed-loop Stimulation algorithm is turned off in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned on and the patient performs a second head up tilt test.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-10-12
• Last updated: 2016-04-05

Locations

2 sites across 1 country: Italy