Trial Outcomes & Findings for BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement (NCT NCT00929474)

NCT ID: NCT00929474

Last Updated: 2019-02-04

Results Overview

The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	QuickOpt QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (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 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.
Overall Study STARTED	8	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

Baseline characteristics by cohort

Measure	QuickOpt n=8 Participants QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (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 n=9 Participants 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.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	74.2 years STANDARD_DEVIATION 10.2 • n=5 Participants	77.7 years STANDARD_DEVIATION 9.8 • n=7 Participants	76 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The BOOST study is prematurely terminated so there were no meaningful measurement from the study.

The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.

Outcome measures

Outcome data not reported

Adverse Events

QuickOpt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	QuickOpt n=8 participants at risk QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (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 n=9 participants at risk 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.
Cardiac disorders Inappropriate therapy delivery	0.00% 0/8	11.1% 1/9 • Number of events 1

Additional Information

Manager of Clinical Studies

St. Jude Medical

Phone: 818-493-2522

Email: klee3@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place