Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

NCT ID: NCT05063006

Last Updated: 2021-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2020-08-04

Brief Summary

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

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.

Conditions

Left Ventricular Assist Device

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

LVAD pump speed dynamically adjusted

Group Type: EXPERIMENTAL

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

Intervention Type: 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 at optimal resting speed

Group Type: ACTIVE_COMPARATOR

Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland

UNKNOWN

Sponsor Role: collaborator

Medtronic Poland Spółka z ograniczoną odpowiedzialnością

INDUSTRY

Sponsor Role: collaborator

AGH University of Science and Technology, Krakow, Poland

UNKNOWN

Sponsor Role: collaborator

Karol Wierzbicki

OTHER

Sponsor Role: lead

Responsible Party

Karol Wierzbicki

Head of Cardiac Transplantation and Mechanical Circulatory Support Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maciej Stapor, MD PhD

Role: STUDY_DIRECTOR

Department of Interventional Cardiology, John Paul II Hospital

Karol Wierzbicki, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital

Locations

John Paul II Hospital

Krakow, Lesser Poland Voivodeship, Poland

Countries

Poland

Other Identifiers

NB.0710.003.2021P

Identifier Type: -

Identifier Source: org_study_id