Left Ventricular Assist DeviceNCT05063006
Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
A study testing Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. and Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging. in people with Left Ventricular Assist Device, run by Karol Wierzbicki at 1 site in Poland.
Trial summary
To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Assist Device
- What is being tested?
- Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. and Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 15 Feb 2017to 4 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hemodynamic instability.
- Non-therapeutic anticoagulation.
- Device or intracardiac thrombus.
- Inflammation.
- Active bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.
Read the 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
- Being tested
- Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings., Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.
- Keywords
- left ventricular assist device, cardiopulmonary exercise test, stress echocardiography, heart failure, mechanical circulatory support, peak VO2
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.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.
Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.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.
| Study group | Role | What they receive |
|---|---|---|
| LVAD pump speed dynamically adjusted | Experimental | Not described Receives: Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging. |
| LVAD pump at optimal resting speed | Active comparator | Not described Receives: Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.
Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.
Measured: Immediately, during cycle ergometer exercise
Secondary outcomes (5)
Change in oxygen consumption
By using the cardiopulmonary exercise test
Measured: Immediately, during cycle ergometer exercise
Change in perceived exertion
By using the Borg rating of perceived exertion scale. Score 6-20 (6 - no exertion, 20 - maximal exertion)
Measured: Immediately, during cycle ergometer exercise
Change in pump speed
By assessing pump speed (RPM)
Measured: Immediately, during cycle ergometer exercise.
Change in pump flow
By assessing pump flow (l/min)
Measured: Immediately, during cycle ergometer exercise
Change in pump power
By assessing pump power (W)
Measured: Immediately, during cycle ergometer exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start15 Feb 2017
- Primary completion31 Jul 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Assist DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- prospective crossover AB/BA study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karol Wierzbicki
- Sponsor type
- University, hospital or other
- Collaborators
- Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland, Medtronic Poland Spółka z ograniczoną odpowiedzialnością, AGH University of Science and Technology, Krakow, Poland
- Responsible party
- Sponsor-investigator, Karol Wierzbicki, John Paul II Hospital, Krakow
- Investigators
- Maciej Stapor, MD PhD, Study director, Department of Interventional Cardiology, John Paul II HospitalKarol Wierzbicki, Assoc Prof, Principal investigator, Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063006
- Sponsor's protocol ID
- NB.0710.003.2021P
- Status last verified
- Oct 2021
- First submitted
- 16 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT05063006
- Acronym / sponsor ID
- NB.0710.003.2021P
- Conditions
- Left Ventricular Assist Device
- Keywords
- left ventricular assist device, cardiopulmonary exercise test, stress echocardiography, heart failure, mechanical circulatory support, peak VO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Karol WierzbickiUniversity, hospital or other
- Collaborators
- Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland, Medtronic Poland Spółka z ograniczoną odpowiedzialnością, AGH University of Science and Technology, Krakow, Poland
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective crossover AB/BA study
| Arm | Type | Receives |
|---|---|---|
| LVAD pump speed dynamically adjusted | Experimental | Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging. |
| LVAD pump at optimal resting speed | Active comparator | Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Hemodynamic instability.
- Non-therapeutic anticoagulation.
- Device or intracardiac thrombus.
- Inflammation.
- Active bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | LVAD pump at optimal resting speed |
| 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. | Other | LVAD pump speed dynamically adjusted |
Primary outcome
Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.
Time frame: Immediately, during cycle ergometer exercise
Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.
5 secondary outcomes
Change in oxygen consumption
Time frame: Immediately, during cycle ergometer exercise
Change in perceived exertion
Time frame: Immediately, during cycle ergometer exercise
Change in pump speed
Time frame: Immediately, during cycle ergometer exercise.
Change in pump flow
Time frame: Immediately, during cycle ergometer exercise
Change in pump power
Time frame: Immediately, during cycle ergometer exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Related trials for Left Ventricular Assist Device
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The JenaValve ALIGN-AR LVAD Registry
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A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure（RESTORATION）
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Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Stapor, MD PhD study director
Department of Interventional Cardiology, John Paul II Hospital
Karol Wierzbicki, Assoc Prof principal investigator
Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings. and Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging. in people with Left Ventricular Assist Device, run by Karol Wierzbicki at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise. (time frame: Immediately, during cycle ergometer exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.