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

Syncope, Vasovagal, Neurally-Mediated Clinical Trial

— TIRECS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573649
• Other study ID #: TIRECS
• Status: Completed
• Phase: N/A
• First received: August 9, 2015
• Last updated: April 1, 2016
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal
• Syncope, Vasovagal, Neurally-Mediated

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Dell'Era Gabriele	Novara
Italy	Pietro Palmisano	Tricase	Lecce

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Cardinale G. Panico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemodynamic response during head up tilt test.	Assessment of the values of systolic blood pressure	45 minutes	No
Primary	Incidence of prodromal symptoms during head up tilt test.	Assessment of patient-reported symptoms during the test	45 minutes	No
Primary	Incidence of syncope during head up tilt test.	Assessment of patient-reported symptoms during the test	45 minutes	No