Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269230
Status:
COMPLETED
Last Update Posted:
2008-11-20
First Post:
2005-12-21
Brief Title:
Attain StarFix Model 4195 Left Ventricular Lead
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Attain StarFix Model 4195 Left Ventricular Lead
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People who have abnormal heart beats or whose heart does not beat on its own may need an electronic device called a pacemaker or a defibrillator Furthermore people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy CRT device A CRT device is implanted surgically just under the skin in the upper chest area This device then helps the heart beat at a regular rhythm by sending electrical signals pacing directly to the heart tissue through flexible wires called leads The device may also be able to stop the heart from beating too fast Three leads are implanted into the chambers of your heart Two of the leads will be placed on the right side of your heart The third lead is placed on the left side of your heart and is the lead being studied
The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular LV Lead This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle It is also steroid-eluting which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted
The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular LV Lead This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle It is also steroid-eluting which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted
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