Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

NCT05063006 | Completed

• 1 other identifier: NB.0710.003.2021P
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Left Ventricular Assist Device

Keywords

left ventricular assist device; cardiopulmonary exercise test; stress echocardiography; heart failure; mechanical circulatory support; peak VO2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in oxygen consumption

  Immediately, during cycle ergometer exercise

• Change in perceived exertion

  Immediately, during cycle ergometer exercise

• Change in pump speed

  Immediately, during cycle ergometer exercise.

• Change in pump flow

  Immediately, during cycle ergometer exercise

• Change in pump power

  Immediately, during cycle ergometer exercise

Study Arms (2)

LVAD pump speed dynamically adjusted

EXPERIMENTAL

Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.

LVAD pump at optimal resting speed

ACTIVE COMPARATOR

Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.

Interventions

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.

LVAD pump speed dynamically adjusted

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.

LVAD pump at optimal resting speed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

John Paul II Hospital

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Maciej Stapor, MD PhD

  Department of Interventional Cardiology, John Paul II Hospital

  STUDY DIRECTOR

• Karol Wierzbicki, Assoc Prof

  Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Cardiac Transplantation and Mechanical Circulatory Support Unit

Model Details: prospective crossover AB/BA study

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 30, 2021
• Study Start: February 15, 2017
• Primary Completion: July 31, 2020
• Study Completion: August 4, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

PL (1)