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Completed

NCT Number: NCT05063006

Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

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

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Key information

Conditions

Left Ventricular Assist Device Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Paul II Hospital

Krakow, Lesser Poland Voivodeship, 31-202, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.

Other

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.

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in oxygen consumption

    Time frame: Immediately, during cycle ergometer exercise

    By using the cardiopulmonary exercise test

  2. 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)

  3. Change in pump speed

    Time frame: Immediately, during cycle ergometer exercise.

    By assessing pump speed (RPM)

  4. Change in pump flow

    Time frame: Immediately, during cycle ergometer exercise

    By assessing pump flow (l/min)

  5. Change in pump power

    Time frame: Immediately, during cycle ergometer exercise

    By assessing pump power (W)

Sponsors and collaborators

Lead sponsor

Karol Wierzbicki

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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