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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
Sponsor:
Collaborators:
Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland
Medtronic Poland Spółka z ograniczoną odpowiedzialnością
AGH University of Science and Technology, Krakow, Poland
Information provided by (Responsible Party):
Karol Wierzbicki, John Paul II Hospital, Krakow

Study Description
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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. Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: prospective 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 : February 15, 2017
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : August 4, 2020

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Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Locations
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Poland
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
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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
More Information
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Responsible Party: Karol Wierzbicki, Head of Cardiac Transplantation and Mechanical Circulatory Support Unit, John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier: NCT05063006    
Other Study ID Numbers: NB.0710.003.2021P
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karol Wierzbicki, John Paul II Hospital, Krakow:
left ventricular assist device
cardiopulmonary exercise test
stress echocardiography
 heart failure
mechanical circulatory support
peak VO2
Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors