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Heart FailurePhase 3MDT-1118 JapanNCT03884504

MDT-1118 Japan DT Study

A Phase 3 study testing Ventricular Assist Device System in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure. The collected data will be used to support Japan regulatory application in expanding market approval for destination therapy. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Heart Failure
What is being tested?
Ventricular Assist Device System
Type of treatment
Medical device
How many people
10 participants
Where
1 siteJapan
Study dates
1 May 2019to 19 Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be ≥20 years of age at consent
  • In judgment of body size, body surface area (BSA) and anatomy by Investigator, patient can be implanted MDT-1118 VAD.
  • Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must 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) for 7 days and/or inotropes for at least 14 days
  • Left ventricular ejection fraction ≤ 25%
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  • LVAD implant is intended as destination therapy
  • Must be able to receive the MDT-1118 VAD
  • Female patients 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 patient has signed the informed consent form and advance directive
  • The patient and the family understand that destination therapy is end-of-life medical care.

Who cannot join

  • Patients with INTERMACS profile 1
  • Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
  • Prior cardiac transplant
  • History of confirmed, untreated abdominal/ thoracic aortic aneurysm > 5 cm, or cardiac aneurysm or intraventricular septum rupture
  • Severe calcification in thoracic aorta
  • Cardiothoracic surgery within 14 days of implantation
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  • Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction1
  • Patients eligible for cardiac transplantation
  • On ventilator support for > 72 hours within the four days immediately prior to implantation
  • Pulmonary embolus within 21 days of implantation as documented by computed tomography (CT) scan or magnetic resonance imaging (MRI)
  • Symptomatic cerebrovascular disease, stroke within 180 days of implantation or > 80% stenosis of carotid or cranial vessels
  • Patient seems difficult to control device by oneself due to cerebral disorder
  • History of drug intoxication or alcohol dependence
  • Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant
  • Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) at the time of screening or right atrial pressure > 20 mmHg on multiple inotropes or right ventricular ejection fraction (RVEF) <15% with clinical signs of severe right heart failure (e.g. Lower extremity edema, ascites or pleural effusions refractory to treatment with diuretics and two inotropic drugs)
  • 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, INR > 2.0 or 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 patient's health status
  • Serum creatinine > 3.0 mg/dL within 72 hours of implantation or requiring dialysis or ultrafiltration
  • Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal within 72 hours of implantation
  • A total bilirubin > 3 mg/dL within 72 hours of implantation, or biopsy proven liver cirrhosis or portal hypertension
  • Patients 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%) or severe pulmonary hypertension
  • Participation in any other study involving investigational drugs or devices
  • 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
  • Patient unwilling or unable to comply with study requirements
  • Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
  • Inadequate family/social support
  • Systemic disease including collagen disease, insulin dependent severe diabetes or irreversible multi-organ failure.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • University of Tokyo

    Tokyo

Other trials in Japan

About this study

Official title: A Prospective, Multi-Center, Single Arm Clinical Study to Evaluate the MDT-1118 Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure. The collected data will be used to support Japan regulatory application in expanding market approval for destination therapy.

Conditions
Heart Failure
Being tested
Ventricular Assist Device System
Keywords
Advanced Heart Failure, Ventricular Assist Device System, Destination Therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ventricular Assist Device SystemDevice

    Ventricular Assist Device System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success at 12 months with the following definitions of success and failure

    Therapy will be considered a success if, at the end of 12 months in the study:

    1. The subject is alive; and
    2. The subject has not had a stroke of Modified Rankin Score ≥ 4; and
    3. The subject retains the originally implanted device, unless the device was removed due to heart recovery, or the patient is electively transplanted.

    Therapy will be considered a failure if, within the 12 months in the study:

    1. The subject dies; or
    2. The subject has a stroke of Modified Rankin Score ≥ 4; or
    3. The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation.

    Measured: Implant to 12 months

Secondary outcomes (4)

  1. Incidence of all adverse events per INTERMACS definition

    Measured: Implant to 12 months

  2. Incidence of all device malfunctions per INTERMACS definition

    Measured: Implant to 12 months

  3. Health Status improvement, as measured by KCCQ

    Measured: Implant to 12 months

  4. Health Status improvement, as measured by EuroQol EQ-5D-5L

    Measured: Implant to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2019
  2. Study start1 May 2019
  3. Primary completion30 Dec 2020
  4. Study completion19 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03884504
Sponsor's protocol ID
MDT18052
Acronym
MDT-1118 Japan
Status last verified
Oct 2022
First submitted
15 Mar 2019
Last updated
21 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ventricular Assist Device System in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success at 12 months with the following definitions of success and failure (time frame: Implant to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03884504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.

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MDT-1118 Japan DT Study (NCT03884504) | AzTrials