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QuickOpt Chronic Study

This study is currently recruiting participants.
Verified January 2013 by St. Jude Medical
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01172067
First received: July 28, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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: June 2015
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172067

Contacts
Contact: Shu Zhang, MD 86-10-88398443 zsfuwai@vip.163.com
Contact: Jia De Huang, MD 86-28-85422343 huangdjmd@yahoo.com

Locations
China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Wei Hua, MD     (86) 10 8839 8290     huangdjmd@yahoo.com    
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: Bailleul Christophe/ Vice President Clinical Operations International Division, 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: January 9, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013