Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device

Karol Wierzbicki

Status: Completed

Conditions: Left Ventricular Assist Device

Treatments: 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.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05063006

NB.0710.003.2021P

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

LVAD pump speed dynamically adjusted

Experimental group

Treatment:

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

LVAD pump at optimal resting speed

Active Comparator group

Treatment:

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