Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04339452
NCT04339452Active, not recruitingNot Applicable

Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: a Single Center Prospective Observational Study

Lucian Archambault Durham III1 site in 1 country30 target enrollmentStarted: May 11, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Intraoperative hemodynamic stability
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥ 18 years old
  • •Ejection fraction ≤ 35%
  • •Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or Left main disease
  • •Adequate Distal target caliber (as determined by the PI or operating surgeon)

Exclusion Criteria

  • •Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:
  • •Patients with structural heart disease requiring cardiopulmonary bypass
  • •Patients with cardiogenic shock who require a period of short-term mechanical circulatory support
  • •Patients with mechanical aortic valve
  • •Patients with previous median sternotomy
  • •Patients with evidence of non-viability on preoperative cardiac MRI or CT scan
  • •Insufficient conduit
  • •BMI over 50
  • •Suspected or known pregnancy

Outcomes

Primary Outcomes

Intraoperative hemodynamic stability

Time Frame: Intraoperative

Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Lucian Archambault Durham III
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lucian Archambault Durham III

Lucian Durham, MD, PhD

Medical College of Wisconsin

Study Sites (1)

Loading locations...

Similar Trials

Withdrawn
Phase 1
Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed TomographyCoronary Artery Disease
NCT00474565Corewell Health East
Not yet recruiting
Not Applicable
Complete Revascularization Via Inferior Part-sternotomyComplete RevascularizationCoronary Artery Bypass GraftingMultivessel Coronary Artery Disease
NCT05835167China National Center for Cardiovascular Diseases260
Completed
Not Applicable
Improving the Results of Heart Bypass Surgery Using New Approaches to Surgery and MedicationCoronary Artery Disease
NCT01047449Sunnybrook Health Sciences Centre250
Completed
Not Applicable
Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating RoomCoronary Artery Disease
NCT00366015London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's80
Unknown
Phase 2
Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary StentCoronary Artery DiseaseMyocardial Ischemia
NCT02568462Amaranth Medical Inc.60