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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL134864-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Biotronik SE & Co. KG | INDUSTRY |
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The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT-On first, then CRT-Off | Experimental | Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period. |
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| CRT-Off first, then CRT-On | Experimental | Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac resynchronization therapy pacemaker (CRT-P) | Device | A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricle End-Systolic Volume Index (LVESVI) | LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area. | baseline, 12 months |
| Number of Subjects Experiencing Any System-Related Complications | This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection. | Approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Admitted to the Hospital for Heart Failure | The total number of subjects hospitalized for heart failure during the study. | Approximately 12 months |
| Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Mei Cha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
82 participants were enrolled, 6 withdrew prior study randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRT-On First, Then CRT-Off | Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period. Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently. |
| FG001 | CRT-Off First, Then CRT-On | Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period. Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CRT-On First, Then CRT-Off | Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period. Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently. |
| 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 Left Ventricle End-Systolic Volume Index (LVESVI) | LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area. | Posted | Mean | Standard Deviation | mL/m^2 | baseline, 12 months |
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Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
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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 | CRT-ON | Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sustained Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness at implant site | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yong-Mei Cha | Mayo Clinic | 507-255-0774 | ycha@mayo.edu |
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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 | Jun 20, 2021 | Dec 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single-center, randomized cross-over study
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Participants randomly assigned to have CRT-ON or OFF. At 6 months, participant CRT function will be crossed over.
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The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood, measured in pg/mL. The change was calculated as the value at 12 months minus the value at 6 months. |
| 6 months, 12 months |
| Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds | In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest. | Approximately 12 months |
| Change in Left Ventricular Ejection Fraction (LVEF) | LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber. | Baseline, 12 months |
| Number of Subjects Who Die in One Year | The total number of subjects to die for any reason during the study. | Approximately 12 months |
| BG001 | CRT-Off First, Then CRT-On | Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period. Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Number of Subjects Experiencing Any System-Related Complications | This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection. | Posted | Count of Participants | Participants | Approximately 12 months |
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|
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| Secondary | Number of Subjects Admitted to the Hospital for Heart Failure | The total number of subjects hospitalized for heart failure during the study. | Posted | Count of Participants | Participants | Approximately 12 months |
|
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| Secondary | Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months | The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood, measured in pg/mL. The change was calculated as the value at 12 months minus the value at 6 months. | Posted | Mean | Standard Deviation | pg/mL | 6 months, 12 months |
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|
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| Secondary | Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds | In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest. | Posted | Count of Participants | Participants | Approximately 12 months |
|
|
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| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber. | Posted | Mean | Standard Deviation | percent | Baseline, 12 months |
|
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|
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| Secondary | Number of Subjects Who Die in One Year | The total number of subjects to die for any reason during the study. | Posted | Count of Participants | Participants | Approximately 12 months |
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| 2 |
| 76 |
| 6 |
| 76 |
| 44 |
| 76 |
| EG001 | CRT-OFF | Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study. | 3 | 76 | 8 | 76 | 29 | 76 |
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Lead dislodgment | General disorders | Systematic Assessment |
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| Electrical Stimulation | General disorders | Systematic Assessment |
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| Deep Vein Thrombosis | General disorders | Systematic Assessment |
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| Diaphragmatic Stimulation | General disorders | Systematic Assessment |
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| Pneumothorax | General disorders | Systematic Assessment |
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| Sepsis | General disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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| Ischemic Stroke | General disorders | Systematic Assessment |
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| Shortness of breath | General disorders | Systematic Assessment |
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| Anemia | General disorders | Systematic Assessment |
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| Hyperglycemia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| COVID-19 | General disorders | Systematic Assessment |
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| Dyspenea | General disorders | Systematic Assessment |
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| Cough | General disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Superiority |