Heart FailureQuickOptNCT00918294
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
A study testing QuickOpt in people with Heart Failure, run by Abbott Medical Devices at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- QuickOpt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Heart Failure
- Being tested
- QuickOpt
- Keywords
- CRT, heart failure, optimization, Timing cycle optimization methods
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuickOptDevice
The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.
| Study group | Role | What they receive |
|---|---|---|
| QuickOpt | Experimental | QuickOpt is an optimization algorithm to program the AV, PV and VV delays Receives: Device: QuickOpt |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the aortic velocity time integral value derived by the QuickOptTM optimization method with that derived by the standard echocardiography optimization methods
Measured: 1 day
Secondary outcomes (2)
Time required for each optimization method considered in this study
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918294
- Sponsor's protocol ID
- QuickOpt Study Asia
- Acronym
- QuickOpt
- Status last verified
- Jan 2019
- First submitted
- 4 Feb 2009
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22490397
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization
- ClinicalTrials.gov ID
- NCT00918294
- Acronym / sponsor ID
- QuickOpt / QuickOpt Study Asia
- Conditions
- Heart Failure
- Keywords
- CRT, heart failure, optimization, Timing cycle optimization methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QuickOpt | Experimental | Device: QuickOptQuickOpt is an optimization algorithm to program the AV, PV and VV delays |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuickOptThe QuickOpt algorithm will suggest values for programming AV, PV and VV delay. | Device | QuickOpt |
Primary outcome
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
2 secondary outcomes
Time required for each optimization method considered in this study
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 22490397Hua 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuickOpt in people with Heart Failure, run by Abbott Medical Devices at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.