Vasovagal SyncopeNCT00292825
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
A study testing Pacemaker treatment, pacemaker programmed as active = CLS and Pacemaker, programmed as passive = VVI 30 beats per minute (bpm) in people with Vasovagal Syncope, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker (closed loop stimulation [CLS]) which can potentially identify an incipient attack and prevent syncope by pacing. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Vasovagal Syncope
- What is being tested?
- Pacemaker treatment, pacemaker programmed as active = CLS and Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Mar 2010
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical problem with vasovagal syncope which motivates considerations concerning pacemaker treatment.
- A positive tilt-table test.
- Exclusion of other causes for syncope by a complete diagnostic work-up allowing only minor cardiac abnormalities
- Syncope for >= 2 years.
- Number of syncopal episodes >= 3
- At least 1 instance of syncope within the last 6 months.
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- A positive tilt-table test which reproduces the clinical syncope and is associated with a clearly abnormal haemodynamic response:
- Vasovagal Syncope International Study (VASIS) type 1 with bradycardia < 40 bpm, or
- VASIS type 2A, or
- VASIS type 2B
- Stable clinical condition
- Able to accept and follow the protocol and give written consent.
Who cannot join
- Conventional indication for pacemaker (i.e. atrioventricular [AV] block)
- Indication for cardiac resynchronisation therapy (i.e. left bundle branch block [LBBB])
- Documented atrial fibrillation or flutter
- Epilepsy
- Congestive heart failure
- History of myocardial infarction (MI) or angina pectoris
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- Serious chronic disease, life expectancy < 3 years.
- Age < 25 years
- Pregnant and lactating women
- Participating in other investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC)
The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker (closed loop stimulation [CLS]) which can potentially identify an incipient attack and prevent syncope by pacing.
Read the detailed description
The treatment of patients with recurrent syncope of vasovagal origin, not precipitated by usual vasovagal factors, and not associated with structural heart disease, is unsolved. The limitations of the conducted 5 pacemaker studies are a significant placebo effect of pacemaker treatment, underpowering and lack of double blinding. The pacemaker intervention has been accelerated dual chamber pacing at the time of bradycardia, which may be too late. However, a pooling of all data indicate a beneficial effect of pacing.
Vasodilatation is an obligate element of all vasovagal syncopal episodes and in many also an early sign associated with the hyperkinetic empty left ventricle which triggers the reflex wave. The principle in closed loop stimulation (CLS) is a continuous surveillance of the impedance in the right ventricle which correlates highly with myocardial contractility. When contractility is increased significantly atrial pacing with prolonged AV delay is commenced. This principle has been used in chronotropic incompetent patients and in one small study of patients with vasovagal syncope with a positive outcome. The hypothesis is that the CLS will potentially identify an incipient vasovagal attack and be able to prevent the drop in cardiac output and bradycardia by early accelerated pacing.
Patients will be treated 12 months with active pacing (CLS) and then crossed over to 12 months with passive pacing (VVI, 30 bpm).
The study will be double blinded, only a technician will know the status of the pacemaker.
- Conditions
- Vasovagal Syncope
- Being tested
- Pacemaker treatment, pacemaker programmed as active = CLS, Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)
- Keywords
- vasovagal syncope, syncope, cardioinhibitory syncope, neurocardiogenic syncope, pacing, closed loop pacing, tilt table
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker treatment, pacemaker programmed as active = CLSDevice
Pacemaker treatment with closed loop function(CLS)
Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)Device
pacemaker treatment as VVI 30 bpm
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period
Measured: 12 months + 12 months
Secondary outcomes (2)
Number of syncopal and presyncopal episodes, active versus passive pacing period
Measured: 12 months+12 months
Quality of life, active versus passive pacing period
Measured: 12 months+12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasovagal SyncopeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Biotronik SE & Co. KG
- Investigators
- Henning Mølgaard, MD, DMSc, Principal investigator, Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292825
- Sponsor's protocol ID
- skejbyH
- Status last verified
- Mar 2010
- First submitted
- 15 Feb 2006
- Last updated
- 1 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC)
- ClinicalTrials.gov ID
- NCT00292825
- Acronym / sponsor ID
- skejbyH
- Conditions
- Vasovagal Syncope
- Keywords
- vasovagal syncope, syncope, cardioinhibitory syncope, neurocardiogenic syncope, pacing, closed loop pacing, tilt table
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Biotronik SE & Co. KG
- Study start
- Feb 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Feb 2006 (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.
The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker (closed loop stimulation [CLS]) which can potentially identify an incipient attack and prevent syncope by pacing.
Detailed description
The treatment of patients with recurrent syncope of vasovagal origin, not precipitated by usual vasovagal factors, and not associated with structural heart disease, is unsolved. The limitations of the conducted 5 pacemaker studies are a significant placebo effect of pacemaker treatment, underpowering and lack of double blinding. The pacemaker intervention has been accelerated dual chamber pacing at the time of bradycardia, which may be too late. However, a pooling of all data indicate a beneficial effect of pacing.
Vasodilatation is an obligate element of all vasovagal syncopal episodes and in many also an early sign associated with the hyperkinetic empty left ventricle which triggers the reflex wave. The principle in closed loop stimulation (CLS) is a continuous surveillance of the impedance in the right ventricle which correlates highly with myocardial contractility. When contractility is increased significantly atrial pacing with prolonged AV delay is commenced. This principle has been used in chronotropic incompetent patients and in one small study of patients with vasovagal syncope with a positive outcome. The hypothesis is that the CLS will potentially identify an incipient vasovagal attack and be able to prevent the drop in cardiac output and bradycardia by early accelerated pacing.
Patients will be treated 12 months with active pacing (CLS) and then crossed over to 12 months with passive pacing (VVI, 30 bpm).
The study will be double blinded, only a technician will know the status of the pacemaker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A clinical problem with vasovagal syncope which motivates considerations concerning pacemaker treatment.
- A positive tilt-table test.
- Exclusion of other causes for syncope by a complete diagnostic work-up allowing only minor cardiac abnormalities
- Syncope for >= 2 years.
- Number of syncopal episodes >= 3
Key exclusion criteria (10 listed)
- Conventional indication for pacemaker (i.e. atrioventricular [AV] block)
- Indication for cardiac resynchronisation therapy (i.e. left bundle branch block [LBBB])
- Documented atrial fibrillation or flutter
- Epilepsy
- Congestive heart failure
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 |
|---|---|---|
| Pacemaker treatment, pacemaker programmed as active = CLSPacemaker treatment with closed loop function(CLS) | Device | – |
| Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)pacemaker treatment as VVI 30 bpm | Device | – |
Primary outcome
Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period
Time frame: 12 months + 12 months
2 secondary outcomes
Number of syncopal and presyncopal episodes, active versus passive pacing period
Time frame: 12 months+12 months
Quality of life, active versus passive pacing period
Time frame: 12 months+12 months
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 1 Apr 2010.
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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.
Henning Mølgaard, MD, DMSc principal investigator
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker treatment, pacemaker programmed as active = CLS and Pacemaker, programmed as passive = VVI 30 beats per minute (bpm) in people with Vasovagal Syncope, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 12 inclusion and 10 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 1 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period (time frame: 12 months + 12 months). 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 1 Apr 2010.