Clinical trial NCT01831544: A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: Six month
Secondary outcomes:
measure: Survival
timeFrame: Two years
measure: Survival
timeFrame: Six month and two years
measure: Incidence of Major Bleeding
timeFrame: Six month and two years
measure: Incidence of All Device Failures and Device Malfunctions
timeFrame: Six month and two years
measure: Incidence of Major Infection
timeFrame: Six month and two years
measure: Incidence of Neurological Dysfunction
timeFrame: Six month and two years
measure: Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
timeFrame: Six month and two years
measure: Functional Status Change, as Measured by NYHA and 6-minute Walk
timeFrame: Six month and two years
measure: Frequency and Rates of Adverse Events(AEs)
timeFrame: Six month and two years
measure: Length of Operative Time and Initial Hospital Stay
timeFrame: Six month and two years
measure: Re-Hospitalizations
timeFrame: Six month and two years
measure: Transplantations
timeFrame: Six month and two years
measure: Explants
timeFrame: Six month and two years
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincents Hospital
city: Vienna
country: Austria
facility: Medical University AKH Vienna
city: Paris
country: France
facility: Hospitalier Pitié-Salpétrière
city: Bad Oeynhausen
country: Germany
facility: The Heart and Diabetes Center NRW
city: Berlin
country: Germany
facility: German Heart Institute Berlin DHZB
city: Duesseldorf
country: Germany
facility: Duesseldorf University Hospital
city: Hamburg
country: Germany
facility: Uniklinik Hamburg Eppendorf (UKE)
city: Hannover
country: Germany
facility: Hannover Medical School MHH
city: Leipzig
country: Germany
facility: University of Leipzig Heart Center
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Foundation
Study officials:
References: