Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266682
Status:
COMPLETED
Last Update Posted:
2006-10-13
First Post:
2005-12-16
Brief Title:
Clinical Investigation of the SelectSecure Pacing Lead
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Clinical Investigation of the SelectSecure Pacing Lead
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People who have a slow heart beat or whose heart does not beat on its own may be in need of an electronic device called a pacemaker A pacemaker is implanted surgically just under the skin in the upper chest area This device helps the heart beat at a regular rhythm by sending electrical signals pacing directly to the heart tissue through flexible wires called leads The purpose of this study is to demonstrate that the SelectSecure Model 3830 lead is safe and effective for both sensing the hearts natural rhythm and pacing the heart when it does not beat on its own This lead will be studied in both the right atrium and right ventricle A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model
Detailed Description:
None
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