Research Project
8126038
DESCRIPTION (provided by applicant): Competing Continuation Grant Application Physiologic Controller for Rotary Blood Pumps Rotary blood pumps are rapidly gaining favor in the field of mechanical circulatory support because of their small size, reliability, and energy efficiency. However the control of these pumps presents some difficulties because of their sensitivity to circulatory load and ability to draw blood under negative pressure. In a Phase I and Phase II effort, we have developed advanced algorithms to mimic the physiological control of blood flow and pressure by developing algorithms suitable for rotary ventricular assist devices, and specifically testing them on the WorldHeart Levacor" VAD system. At this juncture, additional verification testing and validation is required to meet regulatory requirements so that these control improvements may be provided to patients receiving VAD therapy. The specific aims for the grant application are as follows: 1) Implement the controller with the Levacor VAD" system. 2) Conduct preclinical animal studies. 3) Complete an Initial Clinical Trial. 4) Prepare submission to FDA for the Pivotal clinical trial. Preclinical tests are proposed in the grant application for six 30-day animal experiments that will prove safety and effectiveness of the controller in an animal model. Protocols for clinical tests are described to evaluate anti-suction control for false positive detection as well as affirmative response to suction events. Protocols for evaluation of patient recovery and for response to exercise are also proposed as part of the trial. Success of the trial will be demonstrated by, 1) a net decrease in risk to patients by implementation of the automatic control, 2) correlation of device measurements of recovery to independently measured clinical markers for recovery, and 3) improved quality of life for patients by enhanced response to exercise. PUBLIC HEALTH RELEVANCE: Physiologic Controller for Rotary Blood Pumps Physiologically responsive control software for an implantable rotary blood pump has been developed in Phase I and Phase II SBIR programs. The objective of this proposed program is to complete rigorous testing that is required for FDA approval, and begin use of the controller in people.
