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Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

NCT05063006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-10-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland

    collaborator UNKNOWN

  • Medtronic Poland Spółka z ograniczoną odpowiedzialnością

    collaborator INDUSTRY

  • AGH University of Science and Technology, Krakow, Poland

    collaborator UNKNOWN

  • Karol Wierzbicki

    lead OTHER

Principal Investigators

  • Maciej Stapor, MD PhD · Department of Interventional Cardiology, John Paul II Hospital

  • Karol Wierzbicki, Assoc Prof · Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2020-07-31
Completion
2020-08-04

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063006 on ClinicalTrials.gov