MDT-1118 Japan DT Study

Heart Failure Clinical Trial

— MDT-1118 Japan  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884504
• Other study ID #: MDT18052
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: October 19, 2022

Study information

• Verified date: October 2022
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 19, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

1. 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

2. 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.

Exclusion Criteria:

1. Patients with INTERMACS profile 1

2. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)

3. Prior cardiac transplant

4. History of confirmed, untreated abdominal/ thoracic aortic aneurysm > 5 cm, or cardiac aneurysm or intraventricular septum rupture

5. Severe calcification in thoracic aorta

6. Cardiothoracic surgery within 14 days of implantation

7. 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

8. Patients eligible for cardiac transplantation

9. On ventilator support for > 72 hours within the four days immediately prior to implantation

10. Pulmonary embolus within 21 days of implantation as documented by computed tomography (CT) scan or magnetic resonance imaging (MRI)

11. Symptomatic cerebrovascular disease, stroke within 180 days of implantation or > 80% stenosis of carotid or cranial vessels

12. Patient seems difficult to control device by oneself due to cerebral disorder

13. History of drug intoxication or alcohol dependence

14. Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant

15. 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)

16. 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

17. 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)

18. 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

19. Serum creatinine > 3.0 mg/dL within 72 hours of implantation or requiring dialysis or ultrafiltration

20. Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal within 72 hours of implantation

21. A total bilirubin > 3 mg/dL within 72 hours of implantation, or biopsy proven liver cirrhosis or portal hypertension

22. Patients with a mechanical heart valve

23. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy

24. History of severe COPD or severe restrictive lung disease (e.g FEV1 <50%) or severe pulmonary hypertension

25. Participation in any other study involving investigational drugs or devices

26. Severe illness, other than heart disease, which would limit survival to < 3 years

27. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities

28. Pregnancy

29. Patient unwilling or unable to comply with study requirements

30. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator

31. Inadequate family/social support

32. Systemic disease including collagen disease, insulin dependent severe diabetes or irreversible multi-organ failure.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Ventricular Assist Device System
Ventricular Assist Device System

Locations

Country	Name	City	State
Japan	University of Tokyo	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: The subject is alive; and; The subject has not had a stroke of Modified Rankin Score = 4; and; 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: The subject dies; or; The subject has a stroke of Modified Rankin Score = 4; or; The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation.	Implant to 12 months
Secondary	Incidence of all adverse events per INTERMACS definition		Implant to 12 months
Secondary	Incidence of all device malfunctions per INTERMACS definition		Implant to 12 months
Secondary	Health Status improvement, as measured by KCCQ		Implant to 12 months
Secondary	Health Status improvement, as measured by EuroQol EQ-5D-5L		Implant to 12 months