Left Ventricular Assist Device Clinical Trial
Official title:
Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
Verified date | October 2021 |
Source | John Paul II Hospital, Krakow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 4, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | John Paul II Hospital | Krakow | Lesser Poland |
Lead Sponsor | Collaborator |
---|---|
Karol Wierzbicki | AGH University of Science and Technology, Krakow, Poland, Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland, Medtronic Poland Spólka z ograniczona odpowiedzialnoscia |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in oxygen consumption | By using the cardiopulmonary exercise test | Immediately, during cycle ergometer exercise | |
Secondary | Change in perceived exertion | By using the Borg rating of perceived exertion scale. Score 6-20 (6 - no exertion, 20 - maximal exertion) | Immediately, during cycle ergometer exercise | |
Secondary | Change in pump speed | By assessing pump speed (RPM) | Immediately, during cycle ergometer exercise. | |
Secondary | Change in pump flow | By assessing pump flow (l/min) | Immediately, during cycle ergometer exercise | |
Secondary | Change in pump power | By assessing pump power (W) | Immediately, during cycle ergometer exercise |
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