Trial Outcomes & Findings for Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform (NCT NCT03697980)
NCT ID: NCT03697980
Last Updated: 2023-12-04
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
136 participants
Primary outcome timeframe
Implant to 12 months
Results posted on
2023-12-04
Participant Flow
Participants were considered enrolled upon signing informed consent. 12 enrolled participants weren't implanted due to death or screen failure prior to implant.
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
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119
|
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Baseline characteristics by cohort
| Measure |
HVAD
n=124 Participants
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).
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|---|---|
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Age, Continuous
|
57.7 years
STANDARD_DEVIATION 12.3 • n=5 Participants
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|
Sex: Female, Male
Female
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27 Participants
n=5 Participants
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|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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14 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
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3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
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36 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
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2 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Race · White
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73 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Other
|
9 Participants
n=5 Participants
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|
Region of Enrollment
United States
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124 participants
n=5 Participants
|
|
Device Strategy at Time of Implant
Bridge to Transplant
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0 Participants
n=5 Participants
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|
Device Strategy at Time of Implant
Destination Therapy
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124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implant to 12 monthsPopulation: All implanted participants are included.
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.
Outcome measures
| Measure |
HVAD
n=124 Participants
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).
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|---|---|
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Rate of Major Adverse Events
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18.2 % probability of freedom from major AE
Interval 11.8 to 25.8
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Adverse Events
HVAD
Serious events: 109 serious events
Other events: 24 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
HVAD
n=124 participants at risk
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).
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|---|---|
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Blood and lymphatic system disorders
Major Bleeding
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43.5%
54/124 • Number of events 96 • 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.
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Cardiac disorders
Cardiac Arrhythmia
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32.3%
40/124 • Number of events 53 • 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.
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Product Issues
Device Malfunction/Failure
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9.7%
12/124 • Number of events 13 • 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.
|
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Blood and lymphatic system disorders
Hemolysis
|
0.81%
1/124 • Number of events 1 • 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.
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|
Hepatobiliary disorders
Hepatic Dysfunction
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4.8%
6/124 • Number of events 6 • 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.
|
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Cardiac disorders
Hypertension
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2.4%
3/124 • Number of events 4 • 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.
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Infections and infestations
Infection
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47.6%
59/124 • Number of events 95 • 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.
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Cardiac disorders
Myocardial Infarction
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0.00%
0/124 • 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.
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Nervous system disorders
Neurological Dysfunction
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24.2%
30/124 • Number of events 40 • 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.
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Cardiac disorders
Pericardial Fluid Collection
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2.4%
3/124 • Number of events 3 • 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.
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Psychiatric disorders
Psychiatric Episode
|
8.9%
11/124 • Number of events 14 • 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.
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Renal and urinary disorders
Renal Dysfunction
|
20.2%
25/124 • Number of events 28 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.1%
20/124 • Number of events 29 • 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.
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|
Cardiac disorders
Right Heart Failure
|
26.6%
33/124 • Number of events 35 • 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.
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Vascular disorders
Arterial Non-CNS Thromboembolism
|
1.6%
2/124 • Number of events 2 • 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.
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Vascular disorders
Venous Thromboembolism
|
5.6%
7/124 • Number of events 7 • 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.
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Skin and subcutaneous tissue disorders
Wound Dehiscence
|
0.00%
0/124 • 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.
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General disorders
Other Intermacs
|
50.0%
62/124 • Number of events 155 • 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.
|
Other adverse events
| Measure |
HVAD
n=124 participants at risk
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).
|
|---|---|
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Infections and infestations
Infection
|
9.7%
12/124 • Number of events 13 • 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.
|
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General disorders
Other Intermacs
|
12.9%
16/124 • Number of events 22 • 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.
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Additional Information
CRM/MCS Clinical Team
Medtronic Cardiac Rhythm and Heart Failure
Phone: 800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place