Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

Left Ventricular Assist Device Clinical Trial

Official title:

Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063006
• Other study ID #: NB.0710.003.2021P
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: August 4, 2020

Study information

• Verified date: October 2021
• Source: John Paul II Hospital, Krakow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 4, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with implanted cardioverter-defibrillator and third-generation centrifugal CF-LVAD with hydrodynamic bearing (HVAD, Medtronic, Minnesota, United States), at least three months after surgery.

Exclusion Criteria:

• Hemodynamic instability.
• Non-therapeutic anticoagulation.
• Device or intracardiac thrombus.
• Inflammation.
• Active bleeding.

Related Conditions & MeSH terms

• Left Ventricular Assist Device

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	John Paul II Hospital	Krakow	Lesser Poland

Sponsors (4)

Lead Sponsor	Collaborator
Karol Wierzbicki	AGH University of Science and Technology, Krakow, Poland, Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland, Medtronic Poland Spólka z ograniczona odpowiedzialnoscia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.	Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.	Immediately, during cycle ergometer exercise
Secondary	Change in oxygen consumption	By using the cardiopulmonary exercise test	Immediately, during cycle ergometer exercise
Secondary	Change in perceived exertion	By using the Borg rating of perceived exertion scale. Score 6-20 (6 - no exertion, 20 - maximal exertion)	Immediately, during cycle ergometer exercise
Secondary	Change in pump speed	By assessing pump speed (RPM)	Immediately, during cycle ergometer exercise.
Secondary	Change in pump flow	By assessing pump flow (l/min)	Immediately, during cycle ergometer exercise
Secondary	Change in pump power	By assessing pump power (W)	Immediately, during cycle ergometer exercise