Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180570
Status:
SUSPENDED
Last Update Posted:
2015-03-11
First Post:
2005-09-15
Brief Title:
SALT - Success of Active Versus Passive Lead Fixation of Atrial PacingSensing Electrodes
Sponsor:
Guidant Corporation
Organization:
Guidant Corporation
Study Overview
Official Title:
Scandinavian Atrial Lead Trial
Status:
SUSPENDED
Status Verified Date:
2005-09
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:
SALT
Brief Summary:
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
Detailed Description:
This investigation will study and compare 3 types of electrically identical commercially available FineLine II Sterox leads with different fixation mechanisms This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation straight and J-shaped leads if any It will also monitor and document the behavior of the study leads with special reference to electrical parameters and handling Normal measurements are taken at pre-dicharge 1-month 3-month and 12-month follow-up
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