Heartware MVAD® System for advanced heart failure
Research type
Research Study
Full title
Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure
IRAS ID
169932
Contact name
Andrea Sauerland
Contact email
Sponsor organisation
Heartware Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
Heart failure is one of the leading causes of death in the developed world, affecting approximately 2-6% of adults. Improvements in treatment and survival as well as expansion of the aging population have contributed to the rising incidence and prevalence of the disease. Heart transplantation is currently the most effective therapy for advanced heart failure. However, the lack of available donor organs restricts this form of therapy to just over 3700 patients/year worldwide.
Implantable Left Ventricular Assist Device (LVAD) systems are used to treat a patient until a donor is available They extend life expectancy for patients with advanced heart failure who deteriorate while awaiting a donor heart. Approximately 32% of the patients who receive heart transplants are bridged with ventricular assist devices.
The purpose of this trial is to look at the safety and performance of HeartWare Miniaturized Ventricular Assist Device System. The MVAD® Pump is an implantable continuous flow pump that is both lightweight and simple to use. Due to its small size and mechanical simplicity, the MVAD® System may provide benefits not currently available with existing technology that requires abdominal pump pockets. Furthermore, the size of the MVAD® Pump may be suitable for smaller patients who would not otherwise be candidates for implantable VAD support and for patients who cannot tolerate an abdominal surgical procedure.
Participants must be over 18 and showing symptoms of advance heart failure. An MVAD® System will be implanted, and after discharge the participant will attend 6 follow up visits over the next 2 years where they will undergo a number of tests including cardiac, physical and blood tests. 2 hospitals in the UK are taking part in this study.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0012
Date of REC Opinion
19 Jan 2015
REC opinion
Favourable Opinion