UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036550 |
|---|---|
| Receipt number | 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 | 2022/03/16 16:58:54 |
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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
10
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Shiomitsu |
Organization
Medtronic Japan Co., Ltd.
Division name
OU Clinical
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
+81.80.7092.0518
aki.shiomitsu@medtronic.com
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Shiomitsu |
Organization
Medtronic Japan Co., Ltd
Division name
OU Clinical
Zip code
108-0075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
+81.80.7092.0518
Homepage URL
aki.shiomitsu@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2022 | Year | 07 | 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
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041646
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