A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)

Not Applicable

Terminated

Conditions: Heart Failure

Registration Number: NCT01831544

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

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):
1. 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
2. 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) > 47.
Body Surface Area (BSA) < 1.0 m2.
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
Uncorrected moderate to severe aortic insufficiency.
Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening.
Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.
Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, International Normalized Ratio (INR) > 2.0 or Partial Thromboplastin Time (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 subject's health status.
Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis.
Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant.
A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension.
Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation.
Subjects 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 (e.g. FEV1 < 50% predicted value).
Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial.
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.
Pregnancy and breast feeding.
Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD.
Subject unwilling or unable to comply with trial requirements.
Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members or employees of the investigator.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survival	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 Outcome Measures

Name	Time	Method
Survival	Two years	Survival at 24 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 24 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Survival: Number of Participants Who Died by Six Months and Two Years	Six months and two years	Survival: Number of participants who died by six months and two years
Incidence of Major Bleeding	Six months and two years	Incidence of major bleeding, per INTERMACS definition
Incidence of All Device Failures and Device Malfunctions	Six months and two years	Incidence of all device failures and device malfunctions per INTERMACS definition
Incidence of Major Infection	Six months and two years	Incidence of major infection, per INTERMACS definition
Incidence of Neurological Dysfunction	Six months and two years	Incidence of neurological dysfunction per INTERMACS definition
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L	Six month and 24 month visit	Health Status change, as measured by KCCQ and EuroQol EQ-5D-5L. Measured at baseline, 6 month visit and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured. The EQ-5D-5L overall score is between 0 and 1. 1 being the best score and 0 being the worst score. The KCCQ score is between 0 and 100. 100 being the best score and 0 being the worst score.
Functional Status Change, as Measured 6-minute Walk	6 month and 24 month visit	Functional status change, as measured by 6-minute walk. Distance walked in meters in 6 minutes measured at baseline, 6 months and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured
Frequency and Rates of Adverse Events(AEs)	Six months and two years	Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition
Length of Initial Hospital Stay (Days)	Post operation	Length of Initial hospital stay (days) from procedure start to discharge
Re-Hospitalizations	On or before 6 months follow-up and 24 month follow-up	The length of Re-Hospitalization, excluding planned procedures, stay in days.
Transplantations	Six months and two years	Transplantations of subjects enrolled in study and implanted with MVAD System
Explants	Six months and two years	Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System
New York Heart Association (NYHA) Functional Classification Score	Baseline and 6 month and 24 month visit	NYHA score measured at baseline, 6 month visit and 24 month visit. The NYHA scale is from I to IV. A subject with a score of IV indicates more severe heart failure than a subject with a score of I. Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort
Length of Operative Time (Hours)	Implant	Length of operative time (hours)

Trial Locations

Locations (11): St. Vincents Hospital
🇦🇺
Darlinghurst, Australia
Medical University AKH Vienna
🇦🇹
Vienna, Austria
Hospitalier Pitié-Salpétrière
🇫🇷
Paris, France
The Heart and Diabetes Center NRW
🇩🇪
Bad Oeynhausen, Germany
German Heart Institute Berlin DHZB
🇩🇪
Berlin, Germany
Duesseldorf University Hospital
🇩🇪
Düsseldorf, Germany
Uniklinik Hamburg Eppendorf (UKE)
🇩🇪
Hamburg, Germany
Hannover Medical School MHH
🇩🇪
Hanover, Germany
University of Leipzig Heart Center
🇩🇪
Leipzig, Germany
Freeman Hospital
🇬🇧
Newcastle upon Tyne, United Kingdom
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St. Vincents Hospital
🇦🇺Darlinghurst, Australia