Syncope, Vasovagal, Neurally-MediatedTIRECSNCT02573649
The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study
A study testing Closed-loop Stimulation on first and Closed-loop Stimulation off first in people with Syncope, Vasovagal, Neurally-Mediated, run by Azienda Ospedaliera Cardinale G. Panico at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Vasovagal, Neurally-Mediated
- What is being tested?
- Closed-loop Stimulation on first and Closed-loop Stimulation off first
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to head up tilt test
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Dell'Era Gabriele
Novara, Novara
Pietro Palmisano
Tricase, Lecce, 73039
About this study
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
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.
Read the 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.
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Being tested
- Closed-loop Stimulation on first, Closed-loop Stimulation off first
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop Stimulation on firstDevice
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 firstDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CLS-ON first | Active comparator | Closed-loop Stimulation on first Receives: Device: Closed-loop Stimulation on first |
| CLS-OFF first | Active comparator | Closed-loop Stimulation off first Receives: Device: Closed-loop Stimulation off first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic response during head up tilt test.
Assessment of the values of systolic blood pressure
Measured: 45 minutes
Incidence of prodromal symptoms during head up tilt test.
Assessment of patient-reported symptoms during the test
Measured: 45 minutes
Incidence of syncope during head up tilt test.
Assessment of patient-reported symptoms during the test
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, Vasovagal, Neurally-MediatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Palmisano, Azienda Ospedaliera Cardinale G. Panico
- Investigators
- Pietro Palmisano, MD, Principal investigator, Cardiology Unit, Card G. Panico Hospital, Tricase, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573649
- Sponsor's protocol ID
- TIRECS
- Acronym
- TIRECS
- Status last verified
- Apr 2016
- First submitted
- 9 Aug 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02573649
- Acronym / sponsor ID
- TIRECS / TIRECS
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLS-ON first | Active comparator | Device: Closed-loop Stimulation on firstClosed-loop Stimulation on first |
| CLS-OFF first | Active comparator | Device: Closed-loop Stimulation off firstClosed-loop Stimulation off first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications to head up tilt test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop Stimulation on firstClosed-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. | Device | CLS-ON first |
| Closed-loop Stimulation off firstClosed-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. | Device | CLS-OFF first |
Primary outcome
Haemodynamic response during head up tilt test.
Time frame: 45 minutes
Assessment of the values of systolic blood pressure
Incidence of prodromal symptoms during head up tilt test.
Time frame: 45 minutes
Assessment of patient-reported symptoms during the test
Incidence of syncope during head up tilt test.
Time frame: 45 minutes
Assessment of patient-reported symptoms during the test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Palmisano, MD principal investigator
Cardiology Unit, Card G. Panico Hospital, Tricase, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop Stimulation on first and Closed-loop Stimulation off first in people with Syncope, Vasovagal, Neurally-Mediated, run by Azienda Ospedaliera Cardinale G. Panico at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic response during head up tilt test. (time frame: 45 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.