Pressure-Volume Loop During High-Risk PCI
This study will examine the physiologic effects on loading conditions and contractility of the left ventricle during high-risk primary coronary intervention (HRPCI) in the Cardiac Cath Lab. 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.
Conditions:
🦠 Coronary Artery Disease
🗓️ Study Start (Actual) 19 April 2021
🗓️ Primary Completion (Estimated) December 2022
✅ Study Completion (Estimated) December 2023
👥 Enrollment (Estimated) 10
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Detroit, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adult patients (18 years and older) with known coronary artery disease and planned elective HRPCI procedures.

    Exclusion Criteria:

    • * Any patient not considered appropriate for elective HRPCI procedures.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 December 2020
  • First Submitted that Met QC Criteria 18 December 2020
  • First Posted 23 December 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 December 2022
  • Last Update Posted 8 December 2022
  • Last Verified December 2022