QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization (QuickOpt)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
QuickOpt
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring CRT, heart failure, optimization, Timing cycle optimization methods
Eligibility 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
Sites / Locations
- Fu Wai Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QuickOpt
Arm Description
QuickOpt is an optimization algorithm to program the AV, PV and VV delays
Outcomes
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
Secondary Outcome Measures
Time required for each optimization method considered in this study
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
Full Information
NCT ID
NCT00918294
First Posted
February 4, 2009
Last Updated
January 28, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00918294
Brief Title
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
Acronym
QuickOpt
Official Title
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT, heart failure, optimization, Timing cycle optimization methods
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QuickOpt
Arm Type
Experimental
Arm Description
QuickOpt is an optimization algorithm to program the AV, PV and VV delays
Intervention Type
Device
Intervention Name(s)
QuickOpt
Intervention Description
The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time required for each optimization method considered in this study
Time Frame
1 day
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fu Wai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22490397
Citation
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.
Results Reference
derived
Learn more about this trial
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
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