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Sponsors and Collaborators: |
Skejby Hospital Aarhus University Hospital Biotronik GmbH & Co. KG |
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Information provided by: | Skejby Hospital |
ClinicalTrials.gov Identifier: | NCT00292825 |
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 |
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Vasovagal Syncope |
Device: Pacemaker, programmed as active = CLS Device: Pacemaker, programmed as passive = VVI 30 beats per minute (bpm) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC) |
Estimated Enrollment: | 100 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2009 |
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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A positive tilt-table test which reproduces the clinical syncope and is associated with a clearly abnormal haemodynamic response:
Exclusion Criteria:
Contact: Henning Mølgaard, MD, DMSc | +45 8949 6113 | h.molgaard@dadlnet.dk |
Contact: Jens B Johansen, MD, PhD | +45 8949 6133 | brock@dadlnet.dk |
Denmark, Århus N | |
Henning Mølgaard, MD, DMSc | Recruiting |
DK-8200 Århus N, Århus N, Denmark, 8200 |
Principal Investigator: | Henning Mølgaard, MD, DMSc | Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark |
Study ID Numbers: | skejbyH |
Study First Received: | February 15, 2006 |
Last Updated: | October 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00292825 |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
vasovagal syncope syncope cardioinhibitory syncope neurocardiogenic syncope |
pacing closed loop pacing tilt table |
Signs and Symptoms Unconsciousness Consciousness Disorders Neurologic Manifestations |
Neurobehavioral Manifestations Syncope Recurrence Syncope, Vasovagal |
Nervous System Diseases |