Clinical trial NCT05063006: Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
Official title: Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Assist Device
Keywords: left ventricular assist device
cardiopulmonary exercise test
stress echocardiography
heart failure
mechanical circulatory support
peak VO2
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
Collaborators: name: Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland
name: Medtronic Poland Spółka z ograniczoną odpowiedzialnością
name: AGH University of Science and Technology, Krakow, Poland
First posted: 2021-09-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective crossover AB/BA study
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.
timeFrame: Immediately, during cycle ergometer exercise
Secondary outcomes:
measure: Change in oxygen consumption
timeFrame: Immediately, during cycle ergometer exercise
measure: Change in perceived exertion
timeFrame: Immediately, during cycle ergometer exercise
measure: Change in pump speed
timeFrame: Immediately, during cycle ergometer exercise.
measure: Change in pump flow
timeFrame: Immediately, during cycle ergometer exercise
measure: Change in pump power
timeFrame: Immediately, during cycle ergometer exercise
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: John Paul II Hospital
state: Lesser Poland
Study officials:
affiliation: Department of Interventional Cardiology, John Paul II Hospital
name: Maciej Stapor, MD PhD
role: STUDY_DIRECTOR
affiliation: Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital
name: Karol Wierzbicki, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: