Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2021-04-19
2024-09-12
Brief Summary
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This will be performed through analysis of real-time left ventricular (LV) pressure-volume loops (PVL) by continuously recording PVL during HRPCI with the Inca® Pressure-Volume Loop System that will be temporarily placed in the left ventricle during the procedure.
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Detailed Description
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Clinical studies evaluating different MCS devices are not all consistent in terms of patient selection, outcomes examined and overall findings. Therefore, the role of MCS devices in HRPCI is still widely debated. This is reflected in a variable clinical practice pattern and recommendations from professional society guidelines. The investigators believe that having a clear scientific understanding of MCS devices in terms of hemodynamic effects during different stages of these complex procedures may prove helpful in refining the process of appropriate MCS device selection in appropriate clinical setting.
One especially insightful method of examining the MCS devices effect is analyzing the left ventricular (LV) pressure-volume loops (PVL). Continuously recording PVL during HRPCI can provide valuable data on the device effects on loading conditions and contractility of the left ventricle.
In this study, the investigators will collect hemodynamic data in real-time during HRPCI being performed as standard of care and continuously recording left ventricular pressure-volume loop (PVL) throughout the procedure via the Inca® Pressure-Volume Loop System (CD Leycom, Hengelo, The Netherlands).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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High-risk percutaneous coronary intervention
Percutaneous coronary interventions (PCI) deemed high risk based on patient-related risk features, hemodynamic criteria, clinical presentation and complexity of coronary anatomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Henry Ford Health System
OTHER
Responsible Party
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William W. O'Neill
Director, Center for Structural Heart Disease
Principal Investigators
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William O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Mohammad Alqarqaz, MD
Role: STUDY_DIRECTOR
Henry Ford Health System
Mir Babar Basir, DO
Role: STUDY_DIRECTOR
Henry Ford Health System
Locations
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Henry Ford Hospital
Detroit, Michigan, United States
Countries
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Other Identifiers
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9809
Identifier Type: -
Identifier Source: org_study_id
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