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| Name | Class |
|---|---|
| Biotronik, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLS Mode on Biotronik CRT-D | Experimental | All 15 patients will be randomized to this group. Their device will be set in the CLS mode for 1 week. |
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| Accelerometer Mode on Biotronik CRT-D | Active Comparator | All 15 patients will be randomized to this group. Their device will be set in the accelerometer rate responsive mode for 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS Mode on Biotronik CRT-D | Device | Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Performed on day 21. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Hsu, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sulpizio Cardiovascular Center | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10089835 | Background | Alt E. What is the ideal rate-adaptive sensor for patients with implantable cardioverter defibrillators: lessons from cardiac pacing. Am J Cardiol. 1999 Mar 11;83(5B):17D-23D. doi: 10.1016/s0002-9149(98)01038-8. | |
| 18483207 | Background | Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008 May 27;117(21):e350-408. doi: 10.1161/CIRCUALTIONAHA.108.189742. Epub 2008 May 15. No abstract available. |
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12 patients signed consent form. 3 participants dropped out of study prior to randomization. 9 participants were randomized and completed study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | DDDR, Then CLS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2016 |
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| Accelerometer Mode on Biotronik CRT-D | Device | Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire. |
|
| 11817808 | Background | Freedman RA, Hopper DL, Mah J, Hummel J, Wilkoff BL. Assessment of pacemaker chronotropic response: implementation of the Wilkoff mathematical model. Pacing Clin Electrophysiol. 2001 Dec;24(12):1748-54. doi: 10.1046/j.1460-9592.2001.01748.x. |
| 19207785 | Background | Maass AH, Buck S, Nieuwland W, Brugemann J, van Veldhuisen DJ, Van Gelder IC. Importance of heart rate during exercise for response to cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2009 Jul;20(7):773-80. doi: 10.1111/j.1540-8167.2008.01422.x. Epub 2009 Feb 2. |
| 18272507 | Background | Coenen M, Malinowski K, Spitzer W, Schuchert A, Schmitz D, Anelli-Monti M, Maier SK, Estlinbaum W, Bauer A, Muehling H, Kalscheur F, Puerner K, Boergel J, Osswald S. Closed loop stimulation and accelerometer-based rate adaptation: results of the PROVIDE study. Europace. 2008 Mar;10(3):327-33. doi: 10.1093/europace/eun024. Epub 2008 Feb 13. |
| 16360061 | Background | Tse HF, Siu CW, Lee KL, Fan K, Chan HW, Tang MO, Tsang V, Lee SW, Lau CP. The incremental benefit of rate-adaptive pacing on exercise performance during cardiac resynchronization therapy. J Am Coll Cardiol. 2005 Dec 20;46(12):2292-7. doi: 10.1016/j.jacc.2005.02.097. |
| 19782792 | Background | Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS, Kraus WE; HF-ACTION Investigators. Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. doi: 10.1016/j.ahj.2009.07.014. |
| 32757086 | Derived | Hsu JC, Darden D, Alegre M, Birgersdotter-Green U, Feld GK, Hoffmayer KS, Han F, Krummen D, Raissi F, Ho G, Taub PR, Urey MA, Adler E. Effect of closed loop stimulation versus accelerometer on outcomes with cardiac resynchronization therapy: the CLASS trial. J Interv Card Electrophysiol. 2021 Sep;61(3):479-485. doi: 10.1007/s10840-020-00829-4. Epub 2020 Aug 5. |
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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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants were randomized to receive all interventions, therefore baseline characteristics will be reported together. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | meters | Measured on day 14 and day 21. |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Performed on day 14 and day 21. |
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| Primary | 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. | Posted | Mean | Standard Deviation | beats per minute | Performed on day 14 and day 21. |
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| Primary | Patient Preference | At the end of the study, patients were asked about personal preference regarding CLS over DDDR. | Posted | Count of Participants | Participants | Performed on day 21. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLS Mode on Biotronik CRT-D | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG001 | Accelerometer Mode on Biotronik CRT-D | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Hsu, MD, MAS | University of California, San Diego | 858-246-2972 | jonathan.hsu@ucsd.edu |
| Nov 7, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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