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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02573649

Acronym

TIRECS

Enrollment

Registered

2015-10-12

Start date

2015-04-30

Completion date

2015-11-30

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope, Vasovagal, Neurally-Mediated

Brief 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.

Interventions

DEVICEClosed-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.

DEVICEClosed-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Haemodynamic response during head up tilt test.	45 minutes	Assessment of the values of systolic blood pressure
Incidence of prodromal symptoms during head up tilt test.	45 minutes	Assessment of patient-reported symptoms during the test
Incidence of syncope during head up tilt test.	45 minutes	Assessment of patient-reported symptoms during the test

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026