Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180609
Status:
COMPLETED
Last Update Posted:
2009-04-23
First Post:
2005-09-15
Brief Title:
SCANCAP Scandinavian Automatic Capture Study
Sponsor:
Guidant Corporation
Organization:
Guidant Corporation
Study Overview
Official Title:
Scandinavian Automatic Capture Study
Status:
COMPLETED
Status Verified Date:
2009-04
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 primary objective of this study is to document the success rate of the automatic threshold testat pre-discharge in a normal pacemaker patient population implanted with Guidant Insignia Ultra or AVT
Detailed Description:
Currently the optimal programming of the pacemaker output considers both pacemaker efficiency prolonging battery longevity and patient safety adequate safety margin A decrease in the programmed output can be used to increase the projected battery life or to eliminate diaphragmatic or pectoral muscle stimulation An increase in programmed output may be required to account for increasing thresholds after lead implantation The ability of an implanted pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s The Automatic capture feature in the INSIGNIA I UltraAVT pacemaker automatically adapts the ventricular pacing output to ensure capture of the ventricle while optimizing the output voltage The primary objective of this study is to document the success rate of the automatic threshold test in a normal pacemaker patient population by following normal pacemaker follow-up results for 1 year
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