Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
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|ClinicalTrials.gov Identifier: NCT00292825|
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : April 1, 2010
|Condition or disease||Intervention/treatment|
|Vasovagal Syncope||Device: Pacemaker treatment, pacemaker programmed as active = CLS Device: Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC)|
|Study Start Date :||February 2006|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
Device: Pacemaker treatment, pacemaker programmed as active = CLS
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292825
|Henning Mølgaard, MD, DMSc|
|Århus N, Denmark, 8200|
|Principal Investigator:||Henning Mølgaard, MD, DMSc||Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark|