Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-01-01 @ 1:59 AM
Study NCT ID:
NCT05063006
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'prospective crossover AB/BA study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.', 'timeFrame': 'Immediately, during cycle ergometer exercise', 'description': 'Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.'}], 'secondaryOutcomes': [{'measure': 'Change in oxygen consumption', 'timeFrame': 'Immediately, during cycle ergometer exercise', 'description': 'By using the cardiopulmonary exercise test'}, {'measure': 'Change in perceived exertion', 'timeFrame': 'Immediately, during cycle ergometer exercise', 'description': 'By using the Borg rating of perceived exertion scale. Score 6-20 (6 - no exertion, 20 - maximal exertion)'}, {'measure': 'Change in pump speed', 'timeFrame': 'Immediately, during cycle ergometer exercise.', 'description': 'By assessing pump speed (RPM)'}, {'measure': 'Change in pump flow', 'timeFrame': 'Immediately, during cycle ergometer exercise', 'description': 'By assessing pump flow (l/min)'}, {'measure': 'Change in pump power', 'timeFrame': 'Immediately, during cycle ergometer exercise', 'description': 'By assessing pump power (W)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['left ventricular assist device', 'cardiopulmonary exercise test', 'stress echocardiography', 'heart failure', 'mechanical circulatory support', 'peak VO2'], 'conditions': ['Left Ventricular Assist Device']}, 'descriptionModule': {'briefSummary': 'To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.', 'detailedDescription': '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).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Hemodynamic instability.\n* Non-therapeutic anticoagulation.\n* Device or intracardiac thrombus.\n* Inflammation.\n* Active bleeding.'}, 'identificationModule': {'nctId': 'NCT05063006', 'briefTitle': 'Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device', 'organization': {'class': 'OTHER', 'fullName': 'John Paul II Hospital, Krakow'}, 'officialTitle': 'Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device', 'orgStudyIdInfo': {'id': 'NB.0710.003.2021P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LVAD pump speed dynamically adjusted', 'interventionNames': ['Other: Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LVAD pump at optimal resting speed', 'interventionNames': ['Other: Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.']}], 'interventions': [{'name': 'Cardiopulmonary exercise tests with maintained baseline optimal pump speed settings.', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['LVAD pump at optimal resting speed']}, {'name': 'Cardiopulmonary exercise test with gradually increased pump speed depending on live echocardiographic imaging.', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['LVAD pump speed dynamically adjusted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-202', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'John Paul II Hospital', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Maciej Stapor, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Interventional Cardiology, John Paul II Hospital'}, {'name': 'Karol Wierzbicki, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karol Wierzbicki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cor Aegrum Foundation of Cardiac Surgery Development in Cracow, Poland', 'class': 'UNKNOWN'}, {'name': 'Medtronic Poland Spółka z ograniczoną odpowiedzialnością', 'class': 'INDUSTRY'}, {'name': 'AGH University of Science and Technology, Krakow, Poland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiac Transplantation and Mechanical Circulatory Support Unit', 'investigatorFullName': 'Karol Wierzbicki', 'investigatorAffiliation': 'John Paul II Hospital, Krakow'}}}}