QuickOpt Chronic Study

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy
* Device: Optimization using echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system Patient is able to provide written informed consent for study participation Exclusion Criteria: • Patient has limited intrinsic atrial activity (≤ 40 bpm) Patient has persistent or permanent AF Patient has a 2o or 3o heart block Patient's life expectancy is <12 months Patient is <18 years old Patient is pregnant Patient is on IV inotropic agents Patients who are ongoing other devices or agents study Patients with heart transplanted or waiting for heart transplant Patients with Hypertrophic and obstructive cardiomyopathy Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quickopt Group<br>the QuickOpt Group patients will be optimized by QuickOpt(IEGM); | Device: Cardiac Resynchronization Therapy<br>* 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.<br>|
| Active Comparator: Echocardiography group<br>the Echo Group patients will be optimized by Echo. | Device: Optimization using echocardiography<br>* Optimization of the AV/PV and VV delays using echocardiography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline | The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV. | Baseline and12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optimization, CRT, heart failure, Timing cycle optimization methods