QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00918294
First received: February 4, 2009
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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 Intervention
Heart Failure
Device: QuickOpt

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time required for each optimization method considered in this study [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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 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
  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: NCT00918294

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

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Lau, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00918294     History of Changes
Other Study ID Numbers: QuickOpt Study Asia
Study First Received: February 4, 2009
Last Updated: February 22, 2011
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 September 14, 2014