MDT-1118 Japan DT Study (MDT-1118 Japan)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Ventricular Assist Device System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Advanced Heart Failure, Ventricular Assist Device System, Destination Therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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.
Sites / Locations
- University of Tokyo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of all adverse events per INTERMACS definition
Incidence of all device malfunctions per INTERMACS definition
Health Status improvement, as measured by KCCQ
Health Status improvement, as measured by EuroQol EQ-5D-5L
Full Information
NCT ID
NCT03884504
First Posted
March 15, 2019
Last Updated
October 20, 2022
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT03884504
Brief Title
MDT-1118 Japan DT Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
October 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Advanced Heart Failure, Ventricular Assist Device System, Destination Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Ventricular Assist Device System
Intervention Description
Ventricular Assist Device System
Primary Outcome Measure Information:
Title
Success at 12 months with the following definitions of success and failure
Description
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.
Time Frame
Implant to 12 months
Secondary Outcome Measure Information:
Title
Incidence of all adverse events per INTERMACS definition
Time Frame
Implant to 12 months
Title
Incidence of all device malfunctions per INTERMACS definition
Time Frame
Implant to 12 months
Title
Health Status improvement, as measured by KCCQ
Time Frame
Implant to 12 months
Title
Health Status improvement, as measured by EuroQol EQ-5D-5L
Time Frame
Implant to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
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.
Facility Information:
Facility Name
University of Tokyo
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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MDT-1118 Japan DT Study
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