Heart FailureNCT00929474
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
A study testing QuickOpt - SJM CRT (Group 1) in people with Heart Failure, run by Abbott Medical Devices at 2 sites in United States.
Trial summary
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure. Additionally in CRT patients it has been demonstrated that optimizing paced/sensed atrioventricular (AV) and interventricular (V-V) timings leads… 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 - SJM CRT (Group 1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 underwent a CRT replacement within the last two weeks, triggered by either the elective replacement indicator (ERI)/end of life (EOL), or by receiving a CRT-D device as an upgrade from a CRT-P device.
- Patient has received an FDA approved SJM CRT device as a replacement to the old CRT device within the last two weeks.
- Patient has the ability to complete a 6-minute hall walk without any assistance.
- Patient is willing to provide written informed consent.
- Patient has the ability to independently comprehend and complete a QOL questionnaire.
- Patient is geographically stable and is willing to comply with the required follow-up schedule.
Who cannot join
- Patient had paced/sensed AV and/or V-V delay optimization using QuickOpt before CRT replacement.
- Patient had any paced/sensed AV and/or V-V delay optimization within 3 months before CRT replacement.
- Patient has an ability to walk ≥ 450 meters (≥ 1476 feet) in 6 minutes.
- Adequate patient's echocardiography/Doppler images will not be available.
- Patient is expected to receive a heart transplant during the duration of the study.
- Patient has an epicardial ventricular lead system (Active or Inactive).
Show all 13Show fewer
- Patient has limited intrinsic atrial activity (≤ 40 bpm).
- Patient has persistent or permanent atrial fibrillation (AF).
- Patient has 2° or 3° heart block.
- Patient's life expectancy is less than 1 year.
- Patient is less than 18 years old.
- Patient is pregnant.
- Patient is on IV inotropic agents 1 month prior to CRT replacement.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Hattiesburg Clinic, P.A./Southern Heart Center
Hattiesburg, Mississippi, 39401
About this study
Official title: BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure. Additionally in CRT patients it has been demonstrated that optimizing paced/sensed atrioventricular (AV) and interventricular (V-V) timings leads to immediate hemodynamic benefits and further improves cardiac function. Recent studies have shown that optimal paced/sensed AV and V-V delays change over time, which raises the question of how often optimization should be repeated. Thus, frequent re-optimization of these delays might be beneficial for maintaining significant improvement of cardiac function. However, it remains to be evaluated whether timing optimization may be beneficial on patients who have received CRT for a number of years and are now having the CRT device replaced.
Read the detailed description
- This is a prospective, randomized, and multicenter study
- Patients who have received a replacement St. Jude Medical(SJM) CRT device, either CRT-P or CRT-D, within the last two weeks post CRT replacement will be considered for enrollment in the study.
- Baseline measurements will be performed at the time of enrollment.
- Patients are followed up to 12 months post CRT replacement with data collected at 3, 6, 9 and 12 months post CRT replacement.
- Patients will be randomized at enrollment to either Group 1 (use of SJM algorithm to optimize programming) or Group 2 ("Control").
- Conditions
- Heart Failure
- Being tested
- QuickOpt - SJM CRT (Group 1), Control - SJM CRT (Group 2)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuickOpt - SJM CRT (Group 1)Device
The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed AV and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
Control - SJM CRT (Group 2)Device
The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
| Study group | Role | What they receive |
|---|---|---|
| QuickOpt | Experimental | Not described Receives: Device: QuickOpt - SJM CRT (Group 1) |
| Control | Active comparator | Not described Receives: Device: Control - SJM CRT (Group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)
The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 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
- NCT00929474
- Sponsor's protocol ID
- CRD466
- Status last verified
- Jan 2019
- First submitted
- 25 Jun 2009
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
- ClinicalTrials.gov ID
- NCT00929474
- Acronym / sponsor ID
- CRD466
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Jun 2009 (estimated)
- Results
- Posted 23 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure. Additionally in CRT patients it has been demonstrated that optimizing paced/sensed atrioventricular (AV) and interventricular (V-V) timings leads to immediate hemodynamic benefits and further improves cardiac function. Recent studies have shown that optimal paced/sensed AV and V-V delays change over time, which raises the question of how often optimization should be repeated. Thus, frequent re-optimization of these delays might be beneficial for maintaining significant improvement of cardiac function. However, it remains to be evaluated whether timing optimization may be beneficial on patients who have received CRT for a number of years and are now having the CRT device replaced.
Detailed description
- This is a prospective, randomized, and multicenter study
- Patients who have received a replacement St. Jude Medical(SJM) CRT device, either CRT-P or CRT-D, within the last two weeks post CRT replacement will be considered for enrollment in the study.
- Baseline measurements will be performed at the time of enrollment.
- Patients are followed up to 12 months post CRT replacement with data collected at 3, 6, 9 and 12 months post CRT replacement.
- Patients will be randomized at enrollment to either Group 1 (use of SJM algorithm to optimize programming) or Group 2 ("Control").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QuickOpt | Experimental | Device: QuickOpt - SJM CRT (Group 1) |
| Control | Active comparator | Device: Control - SJM CRT (Group 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient underwent a CRT replacement within the last two weeks, triggered by either the elective replacement indicator (ERI)/end of life (EOL), or by receiving a CRT-D device as an upgrade from a CRT-P device.
- Patient has received an FDA approved SJM CRT device as a replacement to the old CRT device within the last two weeks.
- Patient has the ability to complete a 6-minute hall walk without any assistance.
- Patient is willing to provide written informed consent.
- Patient has the ability to independently comprehend and complete a QOL questionnaire.
Key exclusion criteria (13 listed)
- Patient had paced/sensed AV and/or V-V delay optimization using QuickOpt before CRT replacement.
- Patient had any paced/sensed AV and/or V-V delay optimization within 3 months before CRT replacement.
- Patient has an ability to walk ≥ 450 meters (≥ 1476 feet) in 6 minutes.
- Adequate patient's echocardiography/Doppler images will not be available.
- Patient is expected to receive a heart transplant during the duration of the study.
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 |
|---|---|---|
| QuickOpt - SJM CRT (Group 1)The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed AV and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits. | Device | QuickOpt |
| Control - SJM CRT (Group 2)The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation. | Device | Control |
Primary outcome
Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)
Time frame: 12 months
The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuickOpt - SJM CRT (Group 1) in people with Heart Failure, run by Abbott Medical Devices at 2 sites in United States.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2019.