QuickOpt Chronic Study
|Heart Failure||Device: Cardiac Resynchronization Therapy Device: Optimization using echocardiography|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization|
- LV End Systolic Volume (LVESV) [ Time Frame: 12 months ]• To compare LV End Systolic Volume (LVESV) derived by the QuickOptTM optimization method with that derived by the echocardiography optimization methods at 12 months after implantation
- Clinical parameters (NHYA class, SAS and 6 MHWD [ Time Frame: 12 months ]• To compare Clinical parameters (NHYA class, SAS and 6 MHWD ) derived by the QuickOptTM optimization method with that derived by the echocardiography optimization methods at 12 months after implantation
|Study Start Date:||May 2010|
|Study Completion Date:||January 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Quickopt Group
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
Device: Cardiac Resynchronization Therapy
Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
Active Comparator: Echocardiography group
the Echo Group patients will be optimized by Echo.
Device: Optimization using echocardiography
Optimization of the AV/PV and VV delays using echocardiography
Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99.
But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172067
|Beijing, Beijing, China, 100037|