Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
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|ClinicalTrials.gov Identifier: NCT05063006|
Recruitment Status : Completed
First Posted : September 30, 2021
Last Update Posted : October 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Left Ventricular Assist Device||Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.||Not Applicable|
Left ventricular assist devices (LVAD) are becoming a destination therapy in patients with end-stage left ventricular dysfunction. Current generation pumps operate with a fixed rotation speed without the capability of automated speed adjustment. It was shown that acceleration of the pump speed during stress test increases the maximum exercise tolerance. Periodic aortic valve opening (AVO) is used to set up an optimal resting pump speed. The study aimed to evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of AVO during the cardiopulmonary exercise test (CPET).
Patients with implanted third-generation LVADs with hydrodynamic bearing (HVAD, Medtronic, MN, USA) are prospectively enrolled. Two CPETs are performed after resting speed optimization. The first one with maintained baseline pump speed settings, and the second one with gradually increased speed depending on live echocardiographic imaging. The sequence of tests is random.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||prospective crossover AB/BA study|
|Masking:||None (Open Label)|
|Official Title:||Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device|
|Actual Study Start Date :||February 15, 2017|
|Actual Primary Completion Date :||July 31, 2020|
|Actual Study Completion Date :||August 4, 2020|
|Experimental: LVAD pump speed dynamically adjusted||
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.
|Active Comparator: LVAD pump at optimal resting speed||
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.
- Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise. [ Time Frame: Immediately, during cycle ergometer exercise ]Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.
- Change in oxygen consumption [ Time Frame: Immediately, during cycle ergometer exercise ]By using the cardiopulmonary exercise test
- Change in perceived exertion [ Time Frame: Immediately, during cycle ergometer exercise ]By using the Borg rating of perceived exertion scale. Score 6-20 (6 - no exertion, 20 - maximal exertion)
- Change in pump speed [ Time Frame: Immediately, during cycle ergometer exercise. ]By assessing pump speed (RPM)
- Change in pump flow [ Time Frame: Immediately, during cycle ergometer exercise ]By assessing pump flow (l/min)
- Change in pump power [ Time Frame: Immediately, during cycle ergometer exercise ]By assessing pump power (W)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05063006
|John Paul II Hospital|
|Krakow, Lesser Poland, Poland, 31-202|
|Study Director:||Maciej Stapor, MD PhD||Department of Interventional Cardiology, John Paul II Hospital|
|Principal Investigator:||Karol Wierzbicki, Assoc Prof||Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital|