Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 11
- Locations
- 11
- Primary Endpoint
- Survival
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief Summary
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
Detailed Description
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be ≥18 years of age at consent
- •Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
- •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
- •in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes.
- •Left ventricular ejection fraction ≤25%.
- •Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- •The subject has signed the informed consent form.
Exclusion Criteria
- •Body Mass Index (BMI) \>
- •Body Surface Area (BSA) \< 1.0 m
- •Partial or full mechanical circulatory support within thirty days of implant.
- •Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®.
- •Prior cardiac transplant or cardiomyoplasty.
- •History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter \> 5 cm).
- •Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities.
- •On ventilator support for \> 72 hours within the four days immediately prior to implant.
- •Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
- •Symptomatic cerebrovascular disease, stroke within 180 days of implant or \> 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation
Outcomes
Primary Outcomes
Survival
Time Frame: Six month
Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Secondary Outcomes
- Survival(Two years)
- Survival: Number of Participants Who Died by Six Months and Two Years(Six months and two years)
- Incidence of Major Bleeding(Six months and two years)
- Incidence of All Device Failures and Device Malfunctions(Six months and two years)
- Incidence of Major Infection(Six months and two years)
- Incidence of Neurological Dysfunction(Six months and two years)
- Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L(Six month and 24 month visit)
- Functional Status Change, as Measured 6-minute Walk(6 month and 24 month visit)
- Frequency and Rates of Adverse Events(AEs)(Six months and two years)
- Length of Initial Hospital Stay (Days)(Post operation)
- Re-Hospitalizations(On or before 6 months follow-up and 24 month follow-up)
- Transplantations(Six months and two years)
- Explants(Six months and two years)
- New York Heart Association (NYHA) Functional Classification Score(Baseline and 6 month and 24 month visit)
- Length of Operative Time (Hours)(Implant)