An interventional study of Pacemaker treatment, pacemaker programmed as active = CLS and Pacemaker, programmed as passive = VVI 30 beats per minute (bpm) in Vasovagal Syncope, sponsored by Aarhus University Hospital Skejby. Completed at 1 site in Denmark. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2010-04-01.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's planned enrollment of 100 is above the median of 79 across 126 interventional studies indexed under Syncope.
Browse Syncope studies →Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A positive tilt-table test which reproduces the clinical syncope and is associated with a clearly abnormal haemodynamic response:
Exclusion Criteria:
Pacemaker treatment with closed loop function(CLS)
pacemaker treatment as VVI 30 bpm
Recurrence of syncope, active (CLS pacing) versus passive (VVI=30) pacing period
Time frame: 12 months + 12 months
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
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital Skejby