Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 15, 2017

Primary Completion Date

July 31, 2020

Study Completion Date

August 4, 2020

Conditions
Left Ventricular Assist Device
Interventions
OTHER

Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.

Optimal resting LVAD speed settings is defined as periodic aortic valve opening while maintaining the central position of the intraventricular septum, minimizing mitral regurgitation, and preserving the mean systemic blood pressure above 65 mmHg. The aim is to achieve an aortic valve opening ratio of around 25-33% by changing the pump speed at resting conditions.

OTHER

Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.

During the modified speed exercise, when the aortic valve opening ratio rises above 50%, the pump speed is increased by 100 revolutions per minute (RPM). As the aortic valve remains closed the RPM is lowered by 100. Speed increment is not greater than 100 RPM per 45 seconds to enable an echocardiographic analysis of resulting changes and prevent suction events. There is no determined target speed, neither per time period nor maximal.

Trial Locations (1)

31-202

John Paul II Hospital, Krakow

All Listed Sponsors
collaborator

Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland

UNKNOWN

collaborator

Medtronic Poland Spółka z ograniczoną odpowiedzialnością

INDUSTRY

collaborator

AGH University of Science and Technology, Krakow, Poland

UNKNOWN

lead

Karol Wierzbicki

OTHER

NCT05063006 - Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device | Biotech Hunter | Biotech Hunter