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Pressure-Volume Loop During High-Risk PCI

NCT04681313 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-11-14

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Abiomed Inc.

    collaborator INDUSTRY

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • William O'Neill, MD · Henry Ford Health System

  • Mohammad Alqarqaz, MD · Henry Ford Health System

  • Mir Babar Basir, DO · Henry Ford Health System

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-12-01
Completion
2024-09-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681313 on ClinicalTrials.gov