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

NCT01831544 | Terminated Results DMC

• 1 other identifier: HW-MVAD-01
• Study Type: interventional
• Target: 11
• Locations: 4 countries
• Sites: 10

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

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (1)

MVAD® Pump

EXPERIMENTAL

Implant of HeartWare MVAD® System

Device: HeartWare MVAD® System

Interventions

HeartWare MVAD® System DEVICE

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

MVAD® Pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (11)

St. Vincents Hospital

Darlinghurst, 2010, Australia

Location

Medical University AKH Vienna

Vienna, 1090, Austria

Location

Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

The Heart and Diabetes Center NRW

Bad Oeynhausen, 32545, Germany

Location

German Heart Institute Berlin DHZB

Berlin, 13353, Germany

Location

Duesseldorf University Hospital

Düsseldorf, 40225, Germany

Location

Uniklinik Hamburg Eppendorf (UKE)

Hamburg, 20245, Germany

Location

Hannover Medical School MHH

Hanover, 30625, Germany

Location

University of Leipzig Heart Center

Leipzig, 04289, Germany

Location

Freeman Hospital

Newcastle upon Tyne, NE77DN, United Kingdom

Location

Papworth Hospital NHS Foundation

Papworth Everard, CB233RE, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Due to the early suspension of enrollments, the target sample size of 57 was not reached. Fewer than 15 subjects were enrolled, thus no analysis was done.

Results Point of Contact

• Title: Methee Schreuder
• Organization: Medtronic

methee.schreuder@medtronic.com

+31611597388

Study Officials

• Stephan Schueler

  Freeman Hospital Newcastle Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 15, 2013
• Study Start: July 14, 2015
• Primary Completion: September 1, 2015
• Study Completion: February 16, 2017
• Last Updated: September 23, 2025
• Results First Posted: April 7, 2020

Record last verified: 2022-07

Locations

AU (1); GB (2); DE (6); FR (1)