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

Not Applicable

Completed

• Conditions: Syncope, Vasovagal, Neurally-Mediated
• Interventions: Device: Closed-loop Stimulation on first; Device: Closed-loop Stimulation off first

• Registration Number: NCT02573649
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-09
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CLS-ON first	Closed-loop Stimulation on first	Closed-loop Stimulation on first
CLS-OFF first	Closed-loop Stimulation off first	Closed-loop Stimulation off first

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Pietro Palmisano; 🇮🇹 Tricase, Lecce, Italy

Dell'Era Gabriele; 🇮🇹 Novara, Italy