Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
|Vasovagal Syncope||Device: Pacemaker treatment, pacemaker programmed as active = CLS Device: Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 ]
- 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 ]
|Study Start Date:||February 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292825
|Henning Mølgaard, MD, DMSc|
|Århus N, Denmark, 8200|
|Principal Investigator:||Henning Mølgaard, MD, DMSc||Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Denmark|