Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273195
Status:
COMPLETED
Last Update Posted:
2006-10-13
First Post:
2006-01-04
Brief Title:
Clinical Investigation of the Medtronic EnTrust Implantable Cardioverter Defibrillator ICD Model D153ATG
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Clinical Investigation of the Medtronic EnTrust Implantable Cardioverter Defibrillator ICD Model D153ATG
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 dangerously fast heart beat or whose heart is at risk of stopping beating may be in need of an electronic device called an implantable cardioverter defibrillator ICD An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse or shock to the heart to return it to a normal rhythm
The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device A feature of this device allows it to send small painless electrical impulses Anti-tachycardia pacing or ATP to the heart instead of shocking it out of a rhythm that is too fast Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest This device also allows the heart to beat on its own when it can and helping it by pacing or sending it electrical signals when it needs help This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation having too rapid of heart beats in the atrium
This study is now complete and the device has since been approved by the FDA
The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device A feature of this device allows it to send small painless electrical impulses Anti-tachycardia pacing or ATP to the heart instead of shocking it out of a rhythm that is too fast Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest This device also allows the heart to beat on its own when it can and helping it by pacing or sending it electrical signals when it needs help This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation having too rapid of heart beats in the atrium
This study is now complete and the device has since been approved by the FDA
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