Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450684
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2007-03-21
Brief Title:
Cardiac Resynchronization Therapy in Congenital Heart Defects
Sponsor:
Competence Network for Congenital Heart Defects
Organization:
Competence Network for Congenital Heart Defects
Study Overview
Official Title:
Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects
Status:
COMPLETED
Status Verified Date:
2014-10
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:
CARE-CHD
Brief Summary:
The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing which is the main group in this study Optional Immediately after implantation the patients are divided into group A and B randomized single blind for the patient cross-over design
The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed Subjective quality of life assessment questionnaire will also be performed at the defined follow-up intervals and if applicable optional also objective assessment of the physical performance VO2 max
55 patients also including children and adults with CHD are planned to be included in the study The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function ejection fraction and QRS interval
The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed Subjective quality of life assessment questionnaire will also be performed at the defined follow-up intervals and if applicable optional also objective assessment of the physical performance VO2 max
55 patients also including children and adults with CHD are planned to be included in the study The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function ejection fraction and QRS interval
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