Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359203
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2006-07-31
Brief Title:
ISSUE3 International Study on Syncope of Uncertain Etiology 3
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
ISSUE3 International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope
Status:
COMPLETED
Status Verified Date:
2015-09
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:
ISSUE 3 is a multi-center prospective randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope
Detailed Description:
In asystolic neurally-mediated syncope NMS documented by Implantable Loop recorder ILR ISSUE-2 an observational trial showed that pacemaker was effective in reducing the 1-year first syncope recurrence rate from 33 rate before implant ILR phase 1 to 5 rate after implant phase 2 Moreover the control non-asystolic group still continued to have a 41 recurrence rate after the first recurrence of syncope thus supporting the conclusion that the reduction with pacemaker was due to the beneficial effect of pacemaker itself and not to other factors However a formal controlled trial is needed to confirm these findings
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