MDT-1118 Japan DT Study
- Conditions
- Advanced Heart Failure
- Registration Number
- JPRN-UMIN000036550
- Lead Sponsor
- Medtronic Japan Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Not provided
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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