Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02235766
Status:
UNKNOWN
Last Update Posted:
2016-03-04
First Post:
2014-09-03
Brief Title:
Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
Sponsor:
Kell srl
Organization:
Kell srl
Study Overview
Official Title:
Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
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:
CORELAB-CRT
Brief Summary:
Purpose of the observational study is to assess the capability of a satellite tele-echocardiography STE system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory ECL in a real time mode without loss of quality Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated
Detailed Description:
CORELAB-CRT is a prospective multi center Italian observational study All echo images and clips will be transmitted by using an integrated satellite transmission system All echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy CRT All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study
Any compatible market released right atrial right ventricular and left ventricular lead from any manufacturer is allowed
The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7 GE Vivid 9 and GE Vivid I according to the model used in the clinical practice of the hospital
Any compatible market released right atrial right ventricular and left ventricular lead from any manufacturer is allowed
The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7 GE Vivid 9 and GE Vivid I according to the model used in the clinical practice of the hospital
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