Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vasovagal Syncope |
Device: Pacemaker treatment, pacemaker programmed as active = CLS Device: Pacemaker, programmed as passive = VVI 30 beats per minute (bpm) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC) |
- Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period [ Time Frame: 12 months + 12 months ] [ Designated as safety issue: No ]
- Number of syncopal and presyncopal episodes, active versus passive pacing period [ Time Frame: 12 months+12 months ] [ Designated as safety issue: No ]
- Quality of life, active versus passive pacing period [ Time Frame: 12 months+12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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Device: Pacemaker treatment, pacemaker programmed as active = CLS
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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
- Serious chronic disease, life expectancy < 3 years.
- Age < 25 years
- Pregnant and lactating women
- Participating in other investigation
Contacts and Locations| Denmark | |
| Henning Mølgaard, MD, DMSc | |
| Århus N, Denmark, 8200 | |
| Principal Investigator: | Henning Mølgaard, MD, DMSc | Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark |
More Information
No publications provided
| Responsible Party: | Henning Mølgaard M.D., DMSc, Aarhus University Hospital, Skejby; Århus, Denmark |
| ClinicalTrials.gov Identifier: | NCT00292825 History of Changes |
| Other Study ID Numbers: | skejbyH |
| Study First Received: | February 15, 2006 |
| Last Updated: | March 31, 2010 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Skejby Hospital:
|
vasovagal syncope syncope cardioinhibitory syncope neurocardiogenic syncope |
pacing closed loop pacing tilt table |
Additional relevant MeSH terms:
|
Syncope Syncope, Vasovagal Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013