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

• ClinicalTrials.gov Identifier: NCT00918294
• Recruitment Status: Completed
• First Posted: June 11, 2009
• Last Update Posted: January 30, 2019
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

China

Fu Wai Hospital

Beijing, China, 100037

Sponsors and Collaborators

Abbott Medical Devices

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hua W, Wang DM, Cai L, Sun CF, Fu GS, Wang YT, Yan J, Luo ZL, Xu J, Wang ZY, Xu G, Shen FR, Xu W, Wang JF, Ren XJ, Jin W, Zhang N, Lau EO, Zhang S. A prospective study to evaluate the efficacy of an intracardiac electrogram-based atrioventricular and interventricular intervals optimization method in cardiac resynchronization therapy. Chin Med J (Engl). 2012 Feb;125(3):428-33.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00918294
• Other Study ID Numbers: QuickOpt Study Asia
• First Posted: June 11, 2009
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

Keywords provided by Abbott Medical Devices:

CRT; heart failure; optimization; Timing cycle optimization methods

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases