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

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ClinicalTrials.gov Identifier: NCT02573649
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Pietro Palmisano, 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.

Condition or disease Intervention/treatment Phase
Syncope, Vasovagal, Neurally-Mediated Device: Closed-loop Stimulation on first Device: Closed-loop Stimulation off first Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Active Comparator: CLS-ON first
Closed-loop Stimulation on first
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.

Active Comparator: CLS-OFF first
Closed-loop Stimulation off first
Device: 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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573649


Locations
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Italy
Pietro Palmisano
Tricase, Lecce, Italy, 73039
Dell'Era Gabriele
Novara, Italy
Sponsors and Collaborators
Azienda Ospedaliera Cardinale G. Panico
Investigators
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Principal Investigator: Pietro Palmisano, MD Cardiology Unit, Card G. Panico Hospital, Tricase, Italy
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Responsible Party: Pietro Palmisano, physician, Azienda Ospedaliera Cardinale G. Panico
ClinicalTrials.gov Identifier: NCT02573649    
Other Study ID Numbers: TIRECS
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases