Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292825
Status:
COMPLETED
Last Update Posted:
2010-04-01
First Post:
2006-02-15
Brief Title:
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
SCANdinavian Vasovagal SYNCope Pacemaker Investigation SCANSYNC
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None