NCT01172067

QuickOpt Chronic Study

Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.
DEVICE	Optimization using echocardiography	Optimization of the AV/PV and VV delays using echocardiography

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2010-07-29
• Last updated: 2019-10-08
• Results posted: 2019-09-30

Locations

1 site across 1 country: China