Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268320
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2005-12-21
Brief Title:
Clinical Investigation of the Medtronic Concerto Device
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Clinical Investigation of the Medtronic Concerto Cardiac Resynchronization Therapy CRT and Implantable Cardioverter Defibrillator ICD Therapies CRTICD Device
Status:
COMPLETED
Status Verified Date:
2008-09
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:
Heart failure is a progressive disease that decreases the pumping action of the heart This may cause a backup of fluid in the heart and may result in heart beat changes When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat In certain heart failure cases when the two lower chambers of the heart no longer beat in a coordinated manner cardiac resynchronization therapy may be prescribed
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
Atrial tachyarrhythmia AT is the name for rapid beats in the upper chambers of the heart People with AT may experience symptoms such as heart palpitations a racing or pounding feeling in the chest shortness of breath dizziness fatigue or weakness
The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy CRT and Implantable Cardioverter Defibrillator ICD therapies CRTICD device in subjects who are at significant risk of developing atrial tachyarrhythmias
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
Atrial tachyarrhythmia AT is the name for rapid beats in the upper chambers of the heart People with AT may experience symptoms such as heart palpitations a racing or pounding feeling in the chest shortness of breath dizziness fatigue or weakness
The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy CRT and Implantable Cardioverter Defibrillator ICD therapies CRTICD device in subjects who are at significant risk of developing atrial tachyarrhythmias
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