Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508391
Status:
COMPLETED
Last Update Posted:
2010-01-26
First Post:
2007-07-26
Brief Title:
Interventricular Delay of Lumax HF-T for Heart Failure
Sponsor:
Biotronik Inc
Organization:
Biotronik Inc
Study Overview
Official Title:
Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure
Status:
COMPLETED
Status Verified Date:
2010-01
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 this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing OPT is non-inferior to the Lumax HF-T with simultaneous biventricular pacing SIM in patients with heart failure requiring cardiac resynchronization therapy
Detailed Description:
This study is a randomized double-blinded crossover multi-center prospective trial The study will consist of up to 122 subjects who require treatment of advanced heart failure through cardiac resynchronization therapy CRT with back-up defibrillation capabilities Eligible patients will have a successfully implanted BIOTRONIK Lumax HF-T CRT-D system and have received simultaneous biventricular pacing for a minimum of 90 days prior to enrollment The 90-day period is being required to allow the treatment effect of CRT therapy with SIM to be complete and to ensure the patient is receiving a stable and optimal CHF medical regimen The patients will have the interventricular delay feature programmed after a standardized optimization procedure Patients along with study personnel evaluating the study endpoint measures will be blinded to the type of CRT therapy delivered during the study follow-up period
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