BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00929474|
Recruitment Status : Terminated
First Posted : June 29, 2009
Results First Posted : August 23, 2013
Last Update Posted : August 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: QuickOpt - SJM CRT (Group 1) Device: Control - SJM CRT (Group 2)||Phase 4|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement|
|Study Start Date :||June 2009|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
Device: 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.
|Active Comparator: Control||
Device: 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.
- Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI) [ Time Frame: Not assessed ]The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.
- Modified Specific Activity Scale (SAS); Quality-of-life (QOL) Score as Measured by Minnesota Living With Heart Failure (MLHF) Questionnaire [ Time Frame: Not assessed ]
- 6-minute Hall Walk; Intrinsic QRS Width; Echo Measurements (End Diastolic Volume, End Systolic Volume, Ejection Fraction, Left Ventricular Mass, Mitral Regurgitation, Tricuspid Regurgitation, and Interventricular and Intraventricular Mechanical Delays) [ Time Frame: Not assessed ]
- All-cause Cardiovascular and Heart Failure Hospitalizations; All-cause Cardiovascular and Heart Failure Mortality; Changes in Paced/Sensed AV and V-V Delays; Percent Atrial and Ventricular Pacing [ Time Frame: Not assessed ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929474
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|United States, Mississippi|
|Hattiesburg Clinic, P.A./Southern Heart Center|
|Hattiesburg, Mississippi, United States, 39401|