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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036550
Receipt No. R000041646
Scientific 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
Date of disclosure of the study information 2019/04/22
Last modified on 2019/04/19

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Basic information
Public title MDT-1118 Japan DT Study
Acronym MDT-1118 Japan DT Study
Scientific 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
Scientific Title:Acronym MDT-1118 Japan DT Study
Region
Japan

Condition
Condition Advanced Heart Failure
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The primary endpoint is 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
1The subject is alive and
2The subject has not had a stroke of Modified Rankin Score 4 and
3The 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:
1The subject dies; or
2The subject has a stroke of Modified Rankin Score 4 or
3The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation.
Key secondary outcomes 1.Incidence of all adverse events per INTERMACS definition
2.Incidence of all device failures and device malfunctions per INTERMACS definition
3.Health Status improvement, as measured by KCCQ and EuroQol EQ-5D-5L
4.Functional status improvement, as measured by New York Heart Association (NYHA) classification and 6-minute walk test
5.Overall survival
6. Length of initial hospital stay and incidence and causes of re-hospitalizations, number of hospitalizations, length of extra-hospital stay, length without artificial respirator or continuous IV infusion, purpose of IV infusion
7. Analysis of primary endpoint at 3 months and 6 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 MDT-1118 Ventricular Assist Device
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Must be 20 years of age at consent
2. In judgment of body size, body surface area (BSA) and anatomy by Investigator, patient can be implanted MDT-1118 VAD.
3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following)
a. 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
b. 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
4. Left ventricular ejection fraction 25%
5. LVAD implant is intended as destination therapy
6. Must be able to receive the MDT-1118 VAD
7. 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
8. The patient has signed the informed consent form and advance directive
9. The patient and the family understand that destination therapy is end-of-life medical care.
Key exclusion criteria 1Patients with INTERMACS profile 1
2Existence of any ongoing mechanical circulatory support other than an intra-aortic balloon pump
3Prior cardiac transplant
4History of confirmed, untreated abdominal thoracic aortic aneurysm 5 cm, ventricular aneurysm or intraventricular septum rupture
5Severe calcification in thoracic aorta
6Cardiothoracic surgery within 14 days of implantation
7Acute 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 ACCAHA 2007 Guidelines for the Management of Patients with Unstable Angina NonSTElevation Myocardial Infarction1
8Patients eligible for cardiac transplantation
9On ventilator support for 72 hours within the four days immediately prior to implantation
10Pulmonary embolus within 21 days of implantation as documented by computed tomography scan or magnetic resonance imaging (MRI)
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Naohiro
Middle name
Last name Masumoto
Organization Medtronic Japan Co., Ltd.
Division name Cardiovascular Group Clinical
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL +81.3.6776.0056
Email naohiro.masumoto@medtronic.com

Public contact
Name of contact person
1st name Naohiro
Middle name
Last name Masumoto
Organization Medtronic Japan Co., Ltd
Division name Cardiovascular Group Clinical
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL +81.3.6776.0056
Homepage URL
Email naohiro.masumoto@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd
Institute
Department

Funding Source
Organization Medtronic Japan Co., Ltd
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The University of Tokyo IRB
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5800-8743
Email IRBjimu-tokyo@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学病院(宮城県)東京大学医学部附属病院(東京都)大阪大学医学部附属病院(大阪府)、国立循環器病研究センター(大阪府)、九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 24 Day
Date of IRB
2019 Year 04 Month 17 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 19 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041646

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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