QuickOpt Chronic Study

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

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。

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy; Device: Optimization using echocardiography

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (ESTIMATE): July 29, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: heart failure; optimization; CRT; Timing cycle optimization methods
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR-09-063-AP-HF