Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512915
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-08-07
Brief Title:
Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Atriale Vorhofsonde 1699 Mit Sehr Kurzem Bipolabstand Zur Vermeidung Von Far Field Sensing
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Avoid FFS
Brief Summary:
The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period PVAB and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking PVAB
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 the use of a new atrial screw in lead with ultra short tip-ring distance of 11 mm Study Group eliminates the need for individual adjustment of the postventricular atrial blanking period PVAB based on an additional test in the Control Group with standard leads
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