The device that necessitated the clinical trial by Thoratec Corporation, the sponsor, is the Left Ventricular Assist Device (LVAD). The device is meant to assist the left ventricle of the heart to perform its function of pumping blood to the aorta and onwards to vital organs of the body. The device is prescribed for patients whose hearts are not able to function optimally.
The study type employed during the clinical trial of the device was observational, non-randomized, and controlled (St. Jude Medical). It took place in a number of HM II implanting centers. The observational model incorporated prospective and time cohorts in the study design. The hypothesis for the clinical trial was that the Left Ventricular Assist Device (LVAD) works better than Optimal Medical Management (OMM) for patients that are dependent on intravenous inotropic support (St. Jude Medical). The comparison between the two interventions is made on the basis of ambulatory heart failure as defined by the New York Heart Association (St. Jude Medical). Clinical trials on LVAD have also been conducted in Europe.
The total enrollment for the clinical trial involved two hundred patients. Out of the total number of the study population, one hundred and three of the patients were on OMM as the primary intervention while the remaining ninety-seven used LVAD. The start date for the study was October, 2011 while it was verified on June, 2016 hence a study period of four years and seven months (St. Jude Medical). However, for each of the patients, the optimal period for determining the efficacy of the initiatives was twelve months while they were then followed up for an extra one year to determine their quality of life and the extent of functionality.
The sampling method used during the study was non-probability sampling given that it was only strictly unhealthy individuals that were allowed to participate in the clinical trial. Sample randomization was not employed in the study though the extent of its efficacy was enhanced by its multi-center approach in which a total of fifty-four HM II implanting centers were used during the course of the study. The study incorporated time and prospective cohorts. There were two main cohorts depending on the intervention, either OMM or LVAD. The decision on what cohort to join was entirely left to the patients and the investigators. The use of time cohorts enabled researchers in the study to establish a study endpoint.
Following the study, the investigators concluded that the rate of survival among the patients under the study was higher when the intervention was LVAD as opposed to OMM (St. Jude Medical). The rate of survival was also coupled with better quality of life and functionality in which LVAD still performed better than OMM. It is despite LVAD patients experiencing more severe events during the course of the study and the follow up period. The conclusion from the study supports the initial hypothesis that the Left Ventricular Assist Device (LVAD) works better than Optimal Medical Management (OMM) for patients that are dependent on an intravenous inotropic support.
The LVAD study provides a moderate template for conducting clinical trials. A clinical study should take place within an acceptable range of time, that is, the time is enough to enable the researchers to determine the efficacy of the device and its adverse effects once it is used as an intervention. An elaborate and suitable study design is also important in ensuring the success of the clinical trial. It should have adequate control measures that fit in well with the hypothesis as was the case with the LVAD study whose trial results were evaluated in relation to those of OMM. Once an intervention has been undertaken, it is important for those conducting the study to follow-up on the subject in order to determine the quality of life and functionality as was the case with the LVAD study.
Work Cited
St. Jude Medical,. "Risk Assessment And Comparative Effectiveness Of Left Ventricular Assist
Device (LVAD) And Medical Management". Clinicaltrials.gov. N.p., 2016. Web. 6 Aug. 2016.
