An interventional study of CLS Mode on Biotronik CRT-D and Accelerometer Mode on Biotronik CRT-D in Heart Failure, ICD and Chronotropic Incompetence, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient cardiovascular health and quality of life. Patients are being asked to participate in this study if they have a history of heart failure and have or are scheduled to be implanted with a BIOTRONIK ICD that is capable of closed loop stimulation (CLS). CLS is a device setting that works with the cardiovascular system to optimize their heart rate during physical activity. This study is comparing BIOTRONIK's CLS setting to a standard accelerometer setting, which also is able to adjust the heart rate by movement sensors, when necessary. This study has been initiated by Dr. Hsu and Dr. Adler and is financially supported by BIOTRONIK, Inc. There will be approximately 15 participants in this trial.
This study is a prospective, randomized, single-blind crossover study intended to enroll patients who are implanted or are scheduled to be implanted with a Biotronik CLS and accelerometer capable CRT-D device. Patients will serve as their own control group with regard to modes of rate-adaptive pacing. Patients with a previously implanted Biotronik CRT-D device with CLS-capability will be recruited from health care institutions in San Diego and all dedicated functional testing will be performed at the University of California, San Diego (UCSD). The goal enrollment target for analysis will be 15 patients, with up to 20 patients enrolled to allow for withdrawals.
The purpose of this study is to evaluate whether changes to an implanted ICD can improve the functional status of patients with suspected chronotropic incompetence (CI). CI is a condition in which the heart rate is unable to adequately respond to meet the patient's physical demands, such as walking, climbing stairs, or doing household chores. CI is common in patients with cardiovascular disease, particularly in patients with heart failure. Common clinical management of patients with suspected CI is to activate an accelerometer setting in the cardiac resynchronization therapy with defibrillator (CRT-D) device. An accelerometer will adjust the heart rate to fit the physiological circumstances and needs of the patient based on patient movement only. BIOTRONIK is a company that has developed a novel technology included in the settings for CRT-D devices that offers CLS as an alternative to a standard accelerometer. CLS utilizes sensed electrical properties of the heart in order to assess what may be the best heart rate for both physical and mental demands. This study is designed to compare whether patients will benefit from CLS when compared with standard accelerometer technology.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 12 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
All 15 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week.
Device: CLS Mode on Biotronik CRT-D
All 15 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week.
Device: Accelerometer Mode on Biotronik CRT-D
Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Six-minute Walk Distance (6MWD) Test
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.
Time frame: Measured on day 14 and day 21.
RAND-36 Questionnaire
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.
Time frame: Performed on day 14 and day 21.
Cardiopulmonary Exercise Testing (CPET)
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.
Time frame: Performed on day 14 and day 21.
Patient Preference
At the end of the study, patients were asked about personal preference regarding CLS over DDDR.
Time frame: Performed on day 21.
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.
| Milestone | CLS, Then DDDR | DDDR, Then CLS |
|---|---|---|
| Started | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 0 | 0 |
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.
| meters | CLS Mode on Biotronik CRT-D | Accelerometer Mode on Biotronik CRT-D |
|---|---|---|
| Six-minute Walk Distance (6MWD) Test | 293.1 ± 90.2 | 315.1 ± 95.5 |
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.
| score on a scale | CLS Mode on Biotronik CRT-D | Accelerometer Mode on Biotronik CRT-D |
|---|---|---|
| RAND-36 Questionnaire | 550.8 ± 123.9 | 489.3 ± 164.9 |
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.
| beats per minute | CLS Mode on Biotronik CRT-D | Accelerometer Mode on Biotronik CRT-D |
|---|---|---|
| Cardiopulmonary Exercise Testing (CPET) | 110.7 ± 14.7 | 109.7 ± 14.1 |
At the end of the study, patients were asked about personal preference regarding CLS over DDDR.
| Participants | CLS Mode on Biotronik CRT-D | Accelerometer Mode on Biotronik CRT-D |
|---|---|---|
| Patient Preference | 5 | 4 |
Collected over Patients were followed during the whole 3 week study period for any adverse events, assessed on day 0, day 7, day 14 and day 21.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CLS Mode on Biotronik CRT-D | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Accelerometer Mode on Biotronik CRT-D | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 8 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 69 (63.5 to 76.5) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | All Study Participants |
|---|---|
| White | 6 |
| Other | 3 |
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| United States | 9 |
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University of California, San Diego