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

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

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

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: HeartWare MVAD® System

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
    • St. Vincents Hospital
• Austria
  • Vienna, Austria, 1090
    • Medical University AKH Vienna
• France
  • Paris, France, 75013
    • Hospitalier Pitié-Salpétrière
• Germany
  • Bad Oeynhausen, Germany, 32545
    • The Heart and Diabetes Center NRW
  • Berlin, Germany, 13353
    • German Heart Institute Berlin DHZB
  • Düsseldorf, Germany, 40225
    • Duesseldorf University Hospital
  • Hamburg, Germany, 20245
    • Uniklinik Hamburg Eppendorf (UKE)
  • Hanover, Germany, 30625
    • Hannover Medical School MHH
  • Leipzig, Germany, 04289
    • University of Leipzig Heart Center
• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE77DN
    • Freeman Hospital
  • Papworth Everard, United Kingdom, CB233RE
    • Papworth Hospital NHS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be ≥18 years of age at consent

2. 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.
3. Left ventricular ejection fraction ≤25%.
4. 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.
5. The subject has signed the informed consent form.

Exclusion Criteria:

1. Body Mass Index (BMI) > 47.
2. Body Surface Area (BSA) < 1.0 m2.
3. Partial or full mechanical circulatory support within thirty days of implant.
4. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®.
5. Prior cardiac transplant or cardiomyoplasty.
6. History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter > 5 cm).
7. 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.
8. On ventilator support for > 72 hours within the four days immediately prior to implant.
9. Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
10. Symptomatic cerebrovascular disease, stroke within 180 days of implant or > 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation
11. Uncorrected moderate to severe aortic insufficiency.
12. Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening.
13. 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.
14. 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).
15. 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.
16. Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis.
17. Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant.
18. A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension.
19. Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation.
20. Subjects with a mechanical heart valve.
21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 < 50% predicted value).
23. Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial.
24. Severe illness, other than heart disease, which would limit survival to < 3 years.
25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
26. Pregnancy and breast feeding.
27. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD.
28. Subject unwilling or unable to comply with trial requirements.
29. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
30. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MVAD® Pump; Implant of HeartWare MVAD® System	Device: HeartWare MVAD® System; The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	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.	Six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	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.	Two years
Survival: Number of Participants Who Died by Six Months and Two Years	Survival: Number of participants who died by six months and two years	Six months and two years
Incidence of Major Bleeding	Incidence of major bleeding, per INTERMACS definition	Six months and two years
Incidence of All Device Failures and Device Malfunctions	Incidence of all device failures and device malfunctions per INTERMACS definition	Six months and two years
Incidence of Major Infection	Incidence of major infection, per INTERMACS definition	Six months and two years
Incidence of Neurological Dysfunction	Incidence of neurological dysfunction per INTERMACS definition	Six months and two years
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L	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.	Six month and 24 month visit
Functional Status Change, as Measured 6-minute Walk	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	6 month and 24 month visit
Frequency and Rates of Adverse Events(AEs)	Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition	Six months and two years
Length of Initial Hospital Stay (Days)	Length of Initial hospital stay (days) from procedure start to discharge	Post operation
Re-Hospitalizations	The length of Re-Hospitalization, excluding planned procedures, stay in days.	On or before 6 months follow-up and 24 month follow-up
Transplantations	Transplantations of subjects enrolled in study and implanted with MVAD System	Six months and two years
Explants	Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System	Six months and two years
New York Heart Association (NYHA) Functional Classification Score	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	Baseline and 6 month and 24 month visit
Length of Operative Time (Hours)	Length of operative time (hours)	Implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Stephan Schueler, Freeman Hospital Newcastle Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): February 16, 2017

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimated): April 15, 2013

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HW-MVAD-01