Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488410
Status:
COMPLETED
Last Update Posted:
2010-09-08
First Post:
2007-06-18
Brief Title:
SYNCHRO Evaluation of the Forecasts Parameters of Real Time-three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Evaluation of the Forecasts Parameters of Real Time Three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
Status:
COMPLETED
Status Verified Date:
2010-09
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:
Patients showing a normal value of SDI or 8 will randomly be assigned to CRT in ON or OFFmode at one month after implantation In any case of emergency an automated rescue mode is included in the device for the patients in OFF mode
Detailed Description:
Patients with a pathological SDI 8 will as usually be treated by CRT and will serve as control group The study duration for each patient included in the trial is 6 months Patients showing a decreased NYHA score by at least one class and an absence of major cardiovascular event during the period will be considered as good responders The otherswill be considered as no responders
Based on this composite clinical score the percentage of good responders in each group at 6 months is the primary endpoint of the study
Main secondary endpoints
Evaluation of the left ventricular function
Exercice capacity
Serious adverse eventsfrequency
Quality of life SF36
Diagnostic and prognostic value of the Brain Natriuretic PeptideNT pro BNPevolution
Based on this composite clinical score the percentage of good responders in each group at 6 months is the primary endpoint of the study
Main secondary endpoints
Evaluation of the left ventricular function
Exercice capacity
Serious adverse eventsfrequency
Quality of life SF36
Diagnostic and prognostic value of the Brain Natriuretic PeptideNT pro BNPevolution
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