QuickOpt Chronic Study

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Optimization using echocardiography; Device: Cardiac Resynchronization Therapy

• Registration Number: NCT01172067
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Results First Submitted: 2019-05-29
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-27
• Results First Posted: 2019-09-30
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echocardiography group	Optimization using echocardiography	the Echo Group patients will be optimized by Echo.
Quickopt Group	Cardiac Resynchronization Therapy	the QuickOpt Group patients will be optimized by QuickOpt(IEGM);

Primary Outcome Measures

Name	Time	Method
Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline	Baseline and12 months	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.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China