Back to resultsThe Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study (TIRECS)
Primary Purpose
Syncope, Vasovagal, Neurally-Mediated
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Closed-loop Stimulation on first
Closed-loop Stimulation off first
Sponsored by
About this trial
This is an interventional treatment trial for Syncope, Vasovagal, Neurally-Mediated
Eligibility 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
Sites / Locations
- Pietro Palmisano
- Dell'Era Gabriele
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CLS-ON first
CLS-OFF first
Arm Description
Closed-loop Stimulation on first
Closed-loop Stimulation off first
Outcomes
Primary Outcome Measures
Haemodynamic response during head up tilt test.
Assessment of the values of systolic blood pressure
Incidence of prodromal symptoms during head up tilt test.
Assessment of patient-reported symptoms during the test
Incidence of syncope during head up tilt test.
Assessment of patient-reported symptoms during the test
Secondary Outcome Measures
Full Information
NCT ID
NCT02573649
First Posted
August 9, 2015
Last Updated
April 1, 2016
Sponsor
Azienda Ospedaliera Cardinale G. Panico
1. Study Identification
Unique Protocol Identification Number
NCT02573649
Brief Title
The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Cardinale G. Panico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal, Neurally-Mediated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLS-ON first
Arm Type
Active Comparator
Arm Description
Closed-loop Stimulation on first
Arm Title
CLS-OFF first
Arm Type
Active Comparator
Arm Description
Closed-loop Stimulation off first
Intervention Type
Device
Intervention Name(s)
Closed-loop Stimulation on first
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Closed-loop Stimulation off first
Intervention Description
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 Measure Information:
Title
Haemodynamic response during head up tilt test.
Description
Assessment of the values of systolic blood pressure
Time Frame
45 minutes
Title
Incidence of prodromal symptoms during head up tilt test.
Description
Assessment of patient-reported symptoms during the test
Time Frame
45 minutes
Title
Incidence of syncope during head up tilt test.
Description
Assessment of patient-reported symptoms during the test
Time Frame
45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Palmisano, MD
Organizational Affiliation
Cardiology Unit, Card G. Panico Hospital, Tricase, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pietro Palmisano
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
Dell'Era Gabriele
City
Novara
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study
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