Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00632450
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2008-02-29
Brief Title:
EnSite Real-Time Cardiac Performance Measurements RT CPM Study
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
EnSite Real-Time Cardiac Performance Measurements Study a Non-significant Risk Study
Status:
COMPLETED
Status Verified Date:
2019-02
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:
EnSite RT CPM
Brief Summary:
The EnSite Real-Time Cardiac Performance Measurements Study EnSite RT CPM is a multicenter international acute non-significant risk study designed to enroll a maximum of 40 patient The goal of the study is to collect 3-D systolicdiastolic data with the EnSite NavX Mapping system during a CRT implant
Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device
Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device
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