Trial Outcomes & Findings for Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds (NCT NCT02693262)
NCT ID: NCT02693262
Last Updated: 2021-08-05
Results Overview
Cardiovascular health benefits were measured by the six-minute walk distance (6MWD) test. The 6MWD is a standardized field test to evaluate functional exercise performance. Subjects are instructed to walk as far as possible in 6 min on a flat surface. This test was performed twice, once at the end of each intervention period.
COMPLETED
NA
12 participants
Measured on day 14 and day 21.
2021-08-05
Participant Flow
Patients with HFrEF and CI implanted with a CRT-D capable of CLS programming at UCSD were eligible for this study. 102 patients were screened.
12 patients signed consent form. 3 participants dropped out of study prior to randomization. 9 participants were randomized and completed study.
Participant milestones
| Measure |
CLS, Then DDDR
Participants' CRT devices were initially programmed to no rate response (DDD mode) for a 1-week wash-out period and then were programmed to 1 week of CLS followed by 1 week of DDDR.
|
DDDR, Then CLS
Participants' CRT devices were initially programmed to no rate response (DDD mode) for a 1-week wash-out period and then were programmed to 1 week of DDDR followed by 1 week of CLS.
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|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
All participants were randomized to receive all interventions, therefore baseline characteristics will be reported together.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured on day 14 and day 21.Cardiovascular health benefits were measured by the six-minute walk distance (6MWD) test. The 6MWD is a standardized field test to evaluate functional exercise performance. Subjects are instructed to walk as far as possible in 6 min on a flat surface. This test was performed twice, once at the end of each intervention period.
Outcome measures
| Measure |
CLS Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.
CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
Accelerometer Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.
Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
|---|---|---|
|
Six-minute Walk Distance (6MWD) Test
|
293.1 meters
Standard Deviation 90.2
|
315.1 meters
Standard Deviation 95.5
|
PRIMARY outcome
Timeframe: Performed on day 14 and day 21.Quality of life of subjects was measured by the RAND-36 which is a generic 36-item questionnaire that measures eight health-related domains stratified by physical health (physical functioning, role limitations due to physical health, pain, and general health) and emotional health (vitality, role limitations due to emotional problems, social functioning, and mental health). Each scale is directly transformed into a 0-100 scale for a total score range of 0-800. Higher scores represent a more favorable health status. This test was performed twice, once at the end of each intervention period.
Outcome measures
| Measure |
CLS Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.
CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
Accelerometer Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.
Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
|---|---|---|
|
RAND-36 Questionnaire
|
550.8 score on a scale
Standard Deviation 123.9
|
489.3 score on a scale
Standard Deviation 164.9
|
PRIMARY outcome
Timeframe: Performed on day 14 and day 21.Cardiovascular health benefits were determined by measuring the peak heart rate (HR) during Cardiopulmonary exercise testing (CPET). The CPET is performed on a standard treadmill according to the Naughton protocol. During the test, patients inspired room air through a low-resistance mask, and expired oxygen and carbon dioxide partial pressures were measured with a gas analyzer. HR was recorded every 30 seconds during exercise. All patients were encouraged to exercise to maximal effort. This test was performed twice, once at the end of each intervention period.
Outcome measures
| Measure |
CLS Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.
CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
Accelerometer Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.
Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
|---|---|---|
|
Cardiopulmonary Exercise Testing (CPET)
|
110.7 beats per minute
Standard Deviation 14.7
|
109.7 beats per minute
Standard Deviation 14.1
|
PRIMARY outcome
Timeframe: Performed on day 21.At the end of the study, patients were asked about personal preference regarding CLS over DDDR.
Outcome measures
| Measure |
CLS Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.
CLS Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
Accelerometer Mode on Biotronik CRT-D
n=9 Participants
All 9 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.
Accelerometer Mode on Biotronik CRT-D: Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
|
|---|---|---|
|
Patient Preference
|
5 Participants
|
4 Participants
|
Adverse Events
CLS Mode on Biotronik CRT-D
Accelerometer Mode on Biotronik CRT-D
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan Hsu, MD, MAS
University of California, San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place