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Completed

NCT Number: NCT02573649

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

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.

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Key information

Conditions

Syncope, Vasovagal, Neurally-Mediated Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pietro Palmisano, Tricase, Lecce, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop Stimulation on first

Device

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

Device

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.

Primary outcomes

  1. Haemodynamic response during head up tilt test.

    Time frame: 45 minutes

    Assessment of the values of systolic blood pressure

  2. Incidence of prodromal symptoms during head up tilt test.

    Time frame: 45 minutes

    Assessment of patient-reported symptoms during the test

  3. Incidence of syncope during head up tilt test.

    Time frame: 45 minutes

    Assessment of patient-reported symptoms during the test

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Cardinale G. Panico

Other

Registry information

Official study 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

Acronym: TIRECS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 12, 2015
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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