The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial (ENDURANCE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01166347|
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : February 28, 2018
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Device: HeartWare® VAS Device: Control LVAD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||451 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2017|
Experimental: HeartWare® VAS
Implant of HeartWare® Ventricular Assist System
Device: HeartWare® VAS
The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Active Comparator: Control LVAD
Implant of FDA-approved LVADs approved for destination therapy
Device: Control LVAD
Any FDA-approved LVAD for destination therapy.
- Stroke-Free Survival Probability for 2 Years Post Implant [ Time Frame: Implant to 2 years ]The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale >=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.
- Number of Participants With Bleeding [ Time Frame: Implant to two years ]
Number of participants with bleeding, per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. The event of bleeding is defined as: An episode of suspected internal or external bleeding that results in one or more of the following:
- Transfusion of red blood cells as follows:
During first 7 days post implant
- Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant.
After 7 days post implant
- Any transfusion of packed red blood cells (PRBC) after 7 days following implant.
- Number of Participants With Major Infections [ Time Frame: Implant to two years ]Number of participants with major infections, per INTERMACS definition. A major infection is defined as: A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection include Localized non-device infection Percutaneous site and/or pocket infection Internal pump component, inflow or outflow tract infection Sepsis
- Overall Survival at 2 Years [ Time Frame: Implant to two years ]Overall survival is the probability (expressed as a percent of 100) did not died within 2 years post implant via the Kaplan-Meier method. Participants that did not died were censored at the time of last follow-up or 2 years post implant, whichever occurred first.
- Number of Participants With Device Malfunctions [ Time Frame: Implant to two years ]
Number of Participants with device malfunctions per INTERMACS definition. Device malfunction denotes a failure of one or more of the components of the Mechanical Circulatory Support Device (MCSD) system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death. The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure.
Device failure should be classified according to which components fails as follows:
- Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components).
- Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber)
- Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Change from baseline to 2 years ]Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.
- Health Status Change Measured by EuroQol EQ-5D (Version 3L) [ Time Frame: Change from baseline to 2 years ]The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An adjustment was done on the response where the scores were normalized based on this paper: Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66.
- Change in Functional Status Measured by New York Heart Association (NYHA) Class [ Time Frame: Change from baseline to 2 years ]
Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:
I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.
II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).
- Change in Functional Status as Measured by 6-minute Walk [ Time Frame: Change from baseline to 2 years ]Change in functional status, as measured by 6-minute walk test.
- Length of Initial Hospitalization [ Time Frame: Implant to the end of the initial hospitalization ]Length of Initial Hospitalization post implant
- Number of Participants Who Had a Re-hospitalization [ Time Frame: Implant to two years ]Number of participants who had a re-hospitalization while on the device
- Duration of Re-hospitalization [ Time Frame: Implant to two years ]Duration of Re-hospitalization while on device
- Cause of Re-hospitalization [ Time Frame: Implant to two years ]Cause of Re-hospitalization while on device. The reason a participant may have been re-hospitalized was due to an adverse event, the need for an explant, or for various "Other" reasons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166347
|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|