MDT-1118 Japan DT Study

NCT03884504 | Completed Phase 3

• 1 other identifier: MDT18052
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Advanced Heart Failure; Ventricular Assist Device System; Destination Therapy

Outcome Measures

Primary Outcomes (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.

  Implant to 12 months

Secondary Outcomes (4)

• Incidence of all adverse events per INTERMACS definition

  Implant to 12 months

• Incidence of all device malfunctions per INTERMACS definition

  Implant to 12 months

• Health Status improvement, as measured by KCCQ

  Implant to 12 months

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

  Implant to 12 months

Interventions

Ventricular Assist Device System DEVICE

Ventricular Assist Device System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

University of Tokyo

Tokyo, Japan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 21, 2019
• Study Start: May 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: October 19, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

JP (1)