QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization (QuickOpt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918294
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : February 23, 2011
Information provided by:
St. Jude Medical

Brief Summary:
QuickOptTM optimization method provides a quicker, simpler and reliable alternative to standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in patients with CRT-P devices

Condition or disease Intervention/treatment Phase
Heart Failure Device: QuickOpt Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
Study Start Date : September 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: QuickOpt
QuickOpt is an optimization algorithm to program the AV, PV and VV delays
Device: QuickOpt
The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.

Primary Outcome Measures :
  1. To compare the aortic velocity time integral value derived by the QuickOptTM optimization method with that derived by the standard echocardiography optimization methods [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Time required for each optimization method considered in this study [ Time Frame: 1 day ]
  2. Effects of any spontaneous cardiac events during the QuickOpt optimization process and these events are not limited to premature ventricular complex (PVC), pacemaker-mediated tachycardia (PMT), atrial fibrillation (AF) and far-field R-wave oversensing [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 is unable to provide analyzable echocardiogram images
  • Patient's life expectancy is <12 months
  • Patient is <18 years old
  • Patient is pregnant
  • Patient is on IV inotropic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918294

Fu Wai Hospital
Beijing, China, 100037
Sponsors and Collaborators
St. Jude Medical

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elizabeth Lau, St. Jude Medical Identifier: NCT00918294     History of Changes
Other Study ID Numbers: QuickOpt Study Asia
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases