NCT00292825

Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

SCANdinavian Vasovagal SYNCope Pacemaker Investigation (SCANSYNC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vasovagal Syncope

Interventions

Type	Name	Description
DEVICE	Pacemaker treatment, pacemaker programmed as active = CLS	Pacemaker treatment with closed loop function(CLS)
DEVICE	Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)	pacemaker treatment as VVI 30 bpm

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2006-02-16
• Last updated: 2010-04-01

Locations

1 site across 1 country: Denmark