QuickOpt Chronic Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
First received: July 28, 2010
Last updated: May 8, 2015
Last verified: May 2015
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。

Condition Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy
Device: Optimization using echocardiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • LV End Systolic Volume (LVESV) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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

Secondary Outcome Measures:
  • Clinical parameters (NHYA class, SAS and 6 MHWD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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

Estimated Enrollment: 400
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172067

China, Beijing
Fuwai Hospital
Beijing, Beijing, China, 100037
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01172067     History of Changes
Other Study ID Numbers: CR-09-063-AP-HF 
Study First Received: July 28, 2010
Last Updated: May 8, 2015
Health Authority: China: Ethics Committee

Keywords provided by St. Jude Medical:
heart failure
Timing cycle optimization methods

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 26, 2016