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

Azienda Ospedaliera Cardinale G. Panico

Status: Completed

Conditions: Syncope, Vasovagal, Neurally-Mediated

Treatments: Device: Closed-loop Stimulation on first; Device: Closed-loop Stimulation off first

Study type: Interventional

Funder types: Other

Identifiers

NCT02573649

TIRECS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refractory cardioinhibitory vasovagal syncope treated with permanent pacemaker;
• Pacemaker Biotronik with Closed-loop Stimulation algorithm
• Ability to perform a head up tilt test
• Completion of the 18th year of age

Exclusion criteria

• Contraindications to head up tilt test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

CLS-ON first

Active Comparator group

Description:

Closed-loop Stimulation on first

Treatment:

Device: Closed-loop Stimulation on first

CLS-OFF first

Active Comparator group

Description:

Closed-loop Stimulation off first

Treatment:

Device: Closed-loop Stimulation off first