Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307073
Status:
COMPLETED
Last Update Posted:
2006-10-12
First Post:
2006-03-17
Brief Title:
Adapta Pacing System Clinical Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System
Status:
COMPLETED
Status Verified Date:
2006-10
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:
None
Brief Summary:
Pacemakers are implantable devices that pace electrically stimulate the heart Some pacemakers have special programs to treat irregular atrial rhythmstop chambers of the heart beat too fast or too slow Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician Adapta Model ADDR01 is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing MVP feature designed to promote intrinsic conduction natural flow of electricity in the heart by reducing unnecessary ventricular lower chamber of the heart pacing electrical impulses Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system
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