Back to resultsBOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QuickOpt - SJM CRT (Group 1)
Control - SJM CRT (Group 2)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- University of Colorado Hospital
- Hattiesburg Clinic, P.A./Southern Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
QuickOpt
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00929474
Brief Title
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Official Title
BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
5. Study Description
Brief 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 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").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QuickOpt
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
QuickOpt - SJM CRT (Group 1)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control - SJM CRT (Group 2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)
Description
The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hattiesburg Clinic, P.A./Southern Heart Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
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