Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

Sponsor

Karol Wierzbicki (Other)

Overall Status

Completed

CT.gov ID

NCT05063006

Collaborator

Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland (Other), Medtronic Poland Spółka z ograniczoną odpowiedzialnością (Industry), AGH University of Science and Technology, Krakow, Poland (Other)

Enrollment

Location

Arms

41.6

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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.	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

prospective crossover AB/BA studyprospective crossover AB/BA study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

Actual Study Start Date :

Feb 15, 2017

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Aug 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise. [Immediately, during cycle ergometer exercise]
Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.

Secondary Outcome Measures

Change in oxygen consumption [Immediately, during cycle ergometer exercise]
By using the cardiopulmonary exercise test
Change in perceived exertion [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 [Immediately, during cycle ergometer exercise.]
By assessing pump speed (RPM)
Change in pump flow [Immediately, during cycle ergometer exercise]
By assessing pump flow (l/min)
Change in pump power [Immediately, during cycle ergometer exercise]
By assessing pump power (W)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Paul II Hospital	Krakow	Lesser Poland	Poland	31-202

Sponsors and Collaborators

Karol Wierzbicki
Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
AGH University of Science and Technology, Krakow, Poland

Investigators

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