Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE)
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include:
- Overall survival
- Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects.
- Incidence of all device failures and device malfunctions
- Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D
- Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk
The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure|
- The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.
- Survival to 180 Days [ Time Frame: 180 Days ] [ Designated as safety issue: Yes ]All subjects will be followed for date of death until 180 days.
- Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects [ Time Frame: 180 Days ] [ Designated as safety issue: Yes ]Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.
- Incidence of All Device Failures and Device Malfunctions [ Time Frame: 180 Days ] [ Designated as safety issue: Yes ]The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.
- Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline and 180 Days ] [ Designated as safety issue: No ]
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.
The KCCQ's questions are used to calculate scores in ten domains:
Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above
For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
- Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days [ Time Frame: Baseline and 180 Days ] [ Designated as safety issue: No ]
The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.
A longer distance walked is indicative of a better outcome.
- Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D [ Time Frame: Baseline and 180 Days ] [ Designated as safety issue: No ]
The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.
The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
|Study Start Date:||August 2008|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: HeartWare® VAS
Ventricular Assist Device (HeartWare® VAS)
Device: HeartWare® VAS
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751972
Show 35 Study Locations
|Principal Investigator:||Mark Slaughter, MD||Jewish Hospital/Univ of Louisville|
|Principal Investigator:||Keith Aaronson, MD||Univ of Michigan Medical Center|