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The purpose of this study is to better understand how adaptive cardiac resynchronization therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. aCRT has already been approved by the FDA and is being used in patients now, but it is not clear which patients it should be used in compared to normal CRT. This study will include patients who are already scheduled to get a CRT device. The investigators will then randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the investigators will assess the electrical activity of the patients' hearts. After this time, the patient and their doctors will be able to decide if they would like to change the type CRT they have been designated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aCRT Off | Active Comparator | The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm. |
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| aCRT On | Experimental | The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm. |
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| Registry arm | No Intervention | Participants who are not eligible for the randomization because of the implantation of the device that is not capable of delivering aCRT. The team of clinical care providers makes such a clinical decision acting in the patient's best interests. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive cardiac resynchronization therapy | Device | The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. | LV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome. | baseline and 6 months after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute Walk Distance 6 Months Post CRT | Change in 6-minute walk distance 6 months post CRT as compared to baseline | baseline and 6 months after device implantation |
| Change in MLHFQ Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larisa Tereshchenko, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34430943 | Result | Haq KT, Rogovoy NM, Thomas JA, Hamilton C, Lutz KJ, Wirth A, Bender AB, German DM, Przybylowicz R, van Dam P, Dewland TA, Dalouk K, Stecker E, Nazer B, Jessel PM, MacMurdy KS, Zarraga IGE, Beitinjaneh B, Henrikson CA, Raitt M, Fuss C, Ferencik M, Tereshchenko LG. Adaptive Cardiac Resynchronization Therapy Effect on Electrical Dyssynchrony (aCRT-ELSYNC): A randomized controlled trial. Heart Rhythm O2. 2021 Jun 29;2(4):374-381. doi: 10.1016/j.hroo.2021.06.006. eCollection 2021 Aug. |
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| ID | Title | Description |
|---|---|---|
| FG000 | aCRT Off | The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm. Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. |
| FG001 | aCRT On | The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm. Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. |
| FG002 | Registry | Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | aCRT Off | The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm. Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. |
| BG001 | aCRT On |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. | LV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome. | Posted | Median | Inter-Quartile Range | ms | baseline and 6 months after device implantation |
|
6 months
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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 | aCRT Off | The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm. Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larisa Tereshchenko | Cleveland Clinic, Lerner Research Institute | 2164442445 | tereshl@ccf.org |
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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 | Nov 20, 2015 | Jan 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
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|
| Conventional Cardiac Resynchronization Therapy | Device | CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. |
|
|
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score 6 months post-CRT as compared to baseline. The total MLHFQ score range from 0 (zero; the best health) to 105 (the worst health). Higher MLHFQ values represent worse health. Negative values of the change in total MLHFQ score mean the total MLHFQ score decreased six months after device implantation compared to baseline (improvement).
| baseline and 6 months after device implantation |
The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm. Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. |
| BG002 | Registry | Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Left Ventricular Ejection Fraction | Percentage of Left Ventricular Ejection Fraction | Mean | Standard Deviation | Percentage of Left Ventricular EF |
|
| Ischemic cardiomyopathy | Count of Participants | Participants |
|
| QRS duration | Mean | Standard Deviation | ms |
|
| Left Bundle Branch Block | Count of Participants | Participants |
|
| NYHA Class | The New York Heart Association (NYHA) Functional Classification graded patients based on their symptoms and limitations of physical activity. Overall, there are four classes. The higher class the worse. Class III is worse than Class II. Class II patients experience slight limitations in physical activity. Ordinary physical activity results in fatigue, palpitation, and shortness of breath. Class III patients experience marked limitations in physical activity. Less than ordinary physical activity activity causes fatigue, palpitation, and shortness of breath. | Count of Participants | Participants |
|
| OG001 | aCRT On | The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm. Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. |
| OG002 | Registry | Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient. |
|
|
| Secondary | Change in 6-minute Walk Distance 6 Months Post CRT | Change in 6-minute walk distance 6 months post CRT as compared to baseline | Posted | Median | Inter-Quartile Range | m | baseline and 6 months after device implantation |
|
|
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| Secondary | Change in MLHFQ Total Score | Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score 6 months post-CRT as compared to baseline. The total MLHFQ score range from 0 (zero; the best health) to 105 (the worst health). Higher MLHFQ values represent worse health. Negative values of the change in total MLHFQ score mean the total MLHFQ score decreased six months after device implantation compared to baseline (improvement). | Posted | Median | Inter-Quartile Range | units on a scale | baseline and 6 months after device implantation |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | aCRT On | The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm. Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Registry | Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |