A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: July 16, 2010
Last updated: January 9, 2014
Last verified: January 2014
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
Chronic Heart Failure
Device: HeartWare® VAS
Device: Control LVAD
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Stroke-free survival [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.
Secondary Outcome Measures:
- Incidence of bleeding [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Incidence of bleeding, per INTERMACS definition
- Incidence of major infections [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Incidence of major infections, per INTERMACS definition
- Incidence of all device failures and device malfunctions [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Incidence of all device failures and device malfunctions per INTERMACS definition
- Time to death [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]
- Health Status improvement measured by KCCQ and EuroQol EQ-5D [ Time Frame: Two Years ] [ Designated as safety issue: No ]
Health Status improvement as measured by Kansas City Cardiomyopathy Questionaire (KCCQ) and EuroQol EQ-5D.
- Functional status improvement measured by (NYHA)class and 6-minute walk [ Time Frame: Two Years ] [ Designated as safety issue: No ]
Functional status improvement, as measured by New York Heart Association (NYHA)class and 6-minute walk test.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must be ≥18 years of age at consent
- Body Surface Area (BSA) ≥ 1.2 m2
- Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) 3a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or 3b. In Class III or Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days
- Left ventricular ejection fraction < 25%
- LVAD implant is intended as destination therapy
- Must be able to receive either the HeartWare® VAS or control LVAD
- Female patients of childbearing potential must agree to use adequate contraceptive precautions for the duration of the study.
- The patient or legally authorized representative has signed the informed consent form
- Body Mass Index (BMI) > 40
- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
- Prior cardiac transplant.
- History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.
- Cardiothoracic surgery within 30 days of randomization.
- Acute myocardial infarction within 14 days of implant
- Patients eligible for cardiac transplantation
- On ventilator support for > 72 hours within the four days immediately prior to randomization and implant.
- Pulmonary embolus within three weeks of randomization
- Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80% stenosis of carotid or cranial vessels.
- Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant.
- Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) or right atrial pressure > 20 mmHg on multiple inotropes, right ventricular ejection fraction (RVEF) <15% or clinical signs
- Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing.
- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation therapy).
- Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.
- Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis (does not include use of ultra-filtration for fluid removal).
- All three liver enzymes [AST (SGOT), ALT (SGPT), or LDH] > 3 times upper limit of normal or a total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension.
- Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units.
- Patients with a mechanical heart valve .
- Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy
- History of severe COPD or severe restrictive lung disease
- Participation in any other study involving investigational drugs or devices
- Severe illness, other than heart disease, which would limit survival to < 3 years
- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities
- Patient unwilling or unable to comply with study requirements
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166347
||Francis Pagani, MD
||University of Michigan Hospital
||Joseph Rogers, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 16, 2010
||January 9, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014