Status:
ACTIVE_NOT_RECRUITING
Impella Supported OPCABG
Lead Sponsor:
Lucian Archambault Durham III
Collaborating Sponsors:
Abiomed Inc.
Conditions:
Ischemic Cardiomyopathy
Eligibility:
All Genders
18+ years
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04339452
Start Date
May 11 2022
End Date
March 1 2026
Last Update
January 27 2025
Active Locations (1)
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1
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226