Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196144
Status:
COMPLETED
Last Update Posted:
2007-11-26
First Post:
2005-09-12
Brief Title:
FFS - Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers
Status:
COMPLETED
Status Verified Date:
2007-11
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 purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers
Detailed Description:
Far-field R-wave sensing FFS in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the DDD mode to the DDI or VDI mode Inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous may induce atrial tachyarrhythmias can lead to pacemaker syndrome and impairs the reliability of pacemaker Holter data The aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period PVAB based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB
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