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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Syncope, Vasovagal, Neurally-Mediated

Intervention / Treatment
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* Device: Closed-loop Stimulation on first
* Device: Closed-loop Stimulation off first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLS-ON first<br>Closed-loop Stimulation on first | Device: Closed-loop Stimulation on first<br>* 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.<br>|
| Active Comparator: CLS-OFF first<br>Closed-loop Stimulation off first | Device: Closed-loop Stimulation off first<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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