Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy.
The Apogee study is conducted within Medtronic's Product Surveillance Platform.
The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) (NCT03681210) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVAD Left Ventricular Assist Device | Device: HeartWare Ventricular Assist Device Other Names: HVAD The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartWare Ventricular Assist Device | Device | The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Adverse Events | Freedom from event is the probability (expressed as a percent of 100) the participant did not have a major adverse event during 12 months post implant via the Kaplan-Meier method. Participants that did not have a major adverse event were censored at the time of last follow-up in Apogee or their end of study at 12 months post implant, whichever occurred first. Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, CT confirmed stroke, or death. Infection, bleeding, device malfunction and CT confirmed stroke were categorized via Intermacs Version 5.0. Events occurring during the implant procedure were excluded. | Implant to 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients enrolled in DT PAS (NCT03681210) are eligible for enrollment into Apogee and must be consented on the separate Apogee consent. It is expected that the Apogee cohort will be comprised of approximately 100 patients.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas | 72205 | United States | ||
| University of California San Diego |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were considered enrolled upon signing informed consent. 12 enrolled participants weren't implanted due to death or screen failure prior to implant.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HVAD | HeartWare Ventricular Assist Device: The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2020 | Jan 31, 2023 |
Not provided
Not provided
Not provided
Not provided
|
|
| San Diego |
| California |
| 92103 |
| United States |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Stanford University Hospital | Stanford | California | 94305-5330 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| AdventHealth | Orlando | Florida | 32804 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Cardiac Surgery Clinical Research Center | Oak Lawn | Illinois | 60453 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| The Lindner Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Sciences Center | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwalth University Health System | Richmond | Virginia | 23298 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
All implanted participants are included
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HVAD | HeartWare Ventricular Assist Device: The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Device Strategy at Time of Implant | Count of Participants | Participants |
|
| 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 | Rate of Major Adverse Events | Freedom from event is the probability (expressed as a percent of 100) the participant did not have a major adverse event during 12 months post implant via the Kaplan-Meier method. Participants that did not have a major adverse event were censored at the time of last follow-up in Apogee or their end of study at 12 months post implant, whichever occurred first. Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, CT confirmed stroke, or death. Infection, bleeding, device malfunction and CT confirmed stroke were categorized via Intermacs Version 5.0. Events occurring during the implant procedure were excluded. | All implanted participants are included. | Posted | Number | 95% Confidence Interval | % probability of freedom from major AE | Implant to 12 months |
|
|
|
The adverse events are summarized from the date of implant through 12 months while on the HVAD device. Only participants who are implanted with the device are included. All-cause mortality includes all participants who signed consent, regardless if they were implanted.
The Intermacs adverse event definitions are geared towards participants who have a mechanical circulatory support device.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HVAD | HeartWare Ventricular Assist Device: The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD). | 27 | 136 | 109 | 124 | 24 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleeding | Blood and lymphatic system disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Cardiac Arrhythmia | Cardiac disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Device Malfunction/Failure | Product Issues | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Hepatic Dysfunction | Hepatobiliary disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Neurological Dysfunction | Nervous system disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Pericardial Fluid Collection | Cardiac disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Psychiatric Episode | Psychiatric disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Renal Dysfunction | Renal and urinary disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Right Heart Failure | Cardiac disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Arterial Non-CNS Thromboembolism | Vascular disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Venous Thromboembolism | Vascular disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Other Intermacs | General disorders | Intermacs Ver. 5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Intermacs Ver. 5.0 | Systematic Assessment |
| |
| Other Intermacs | General disorders | Intermacs Ver. 5.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRM/MCS Clinical Team | Medtronic Cardiac Rhythm and Heart Failure | 800-328-2518 | MedtronicCRMtrials@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2022 | Jan 31, 2023 | SAP_001.pdf |
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|