Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-04 @ 4:49 PM
Study NCT ID:
NCT02235766
Status:
UNKNOWN
Last Update Posted:
2016-03-04
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
Sponsor:
Kell s.r.l.
Organization:
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:
False
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?: