Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187200
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2005-09-10
Brief Title:
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular VV Timing in Heart Failure Patients
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:
None
Brief Summary:
The purpose of the study is to evaluate the benefit of interventricular V-V delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator CRT-D devices The primary endpoint of this study is CRT responder rate
For patients enrolled with new CRT-D systems patients are considered non-responders if BOTH of the following requirements are fulfilled
10 improvement in 6-minute hall walk and
no class improvement or worsening in New York Heart Association NYHA scale
For those receiving CRT-D devices as replacements of older CRT-D systems patients are considered non-responders if BOTH of the following requirements are fulfilled
1 heart failure HF related hospitalization and
no class improvement or worsening in NYHA scale
For patients enrolled with new CRT-D systems patients are considered non-responders if BOTH of the following requirements are fulfilled
10 improvement in 6-minute hall walk and
no class improvement or worsening in New York Heart Association NYHA scale
For those receiving CRT-D devices as replacements of older CRT-D systems patients are considered non-responders if BOTH of the following requirements are fulfilled
1 heart failure HF related hospitalization and
no class improvement or worsening in NYHA scale
Detailed Description:
Study Methods
This is a prospective randomized simultaneous biventricular BiV pacing vs sequential BiV pacing study
Any patient that receives an FDA approved St Jude Medical SJM CRT-D with V-V timing is eligible for enrollment
At 3 months post enrollment or at implant for CRT-D replacements patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screeningrandomization visit
Patients are followed for a period of 6 months post randomization
Enrollment 1 week pre CRT-D implant to 2 weeks post CRT-D implant
ScreeningRandomization Visit 3 months post enrollment
Follow-up Visit 6 months post randomization
Total of centers - 80 centers
Sample size - 800 patients screened for CRT non-responders
This is a prospective randomized simultaneous biventricular BiV pacing vs sequential BiV pacing study
Any patient that receives an FDA approved St Jude Medical SJM CRT-D with V-V timing is eligible for enrollment
At 3 months post enrollment or at implant for CRT-D replacements patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screeningrandomization visit
Patients are followed for a period of 6 months post randomization
Enrollment 1 week pre CRT-D implant to 2 weeks post CRT-D implant
ScreeningRandomization Visit 3 months post enrollment
Follow-up Visit 6 months post randomization
Total of centers - 80 centers
Sample size - 800 patients screened for CRT non-responders
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