Artificial Heart Patients Discharged Home with a Portable Pneumatic Driver – The Pivotal US Clinical Trial Experience
| Autor: | Vigneshwar Kasirajan, M.L.S. David, M.F. McGrath, Fardad Esmailian, D.G. Tang, D.E. Jarowszeki, James W. Long, Nahush A. Mokadam, C. Smith, Charles W. Hoopes, M. Bowdish, Francisco A. Arabia, Lyle D. Joyce, G. Jennifer |
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| Rok vydání: | 2013 |
| Předmět: |
Pulmonary and Respiratory Medicine
Transplantation medicine.medical_specialty Pediatrics Randomization business.industry Cardiac index Investigational device exemption law.invention Clinical trial law Artificial heart Emergency medicine Cohort medicine Surgery Cardiology and Cardiovascular Medicine Adverse effect business |
| Zdroj: | The Journal of Heart and Lung Transplantation. 32:S149 |
| ISSN: | 1053-2498 |
| Popis: | Purpose This is a Food and Drug Administration (FDA) designated Investigational Device Exemption (IDE # G0902212) US Pivotal Trial of a portable pneumatic driver (PPD) for the Total Artificial Heart (TAH). The study is funded by the manufacturer of the TAH and PPD (Syncardia, Inc Tuczon, Az). The Study data will be fully reviewed and adjudicated November 30, 2012 and will be available for the full abstract and subsequent paper. Methods and Materials 1. The PPD is suitable to support stable TAH patients both in hospital and after discharge. 2. The patients and caregivers can be safely trained in out of hospital care with a low adverse event profile. Results Prospective multicenter study of US sites without randomization. Stable TAH patients will be transferred to a PPD. Once on the PPD, the adverse events (based on Intermacs Definitions) will be compared to a cohort of similar patients from the postmarket data on stable TAH patients in hospital. Then the adverse events on the PPD in hospital will be compared to events out of the hospital after discharge. The study duration will be 90 days after discharge, transplantation or death whichever occurs first. Safety analysis will be done on all patients currently on the PPD even if beyond the 90 days. Conclusions A cohort of 30 patients discharged from the hospital on the PPD followed for 90 days, transplantation or death (whichever occurs earlier). Up to 60 patients will be enrolled and safety analysis will be done on all patients at latest follow up. The primary endpoints are: 1. Ninety five percent of patients will have a cardiac index of 2.2 L/mim/m2 throughout the study period; 2. The PPD cohort experiences a rate of death or preclusion from transplant that is no more than 10% higher than the rate of death or preclusion from transplant for the post market TAH cohort while in the hospital; 3. The overall out-of-hospital adverse event profile is clinically comparable to the in-hospital adverse event profile while on PPD support. |
| Databáze: | OpenAIRE |
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