Trials / Active Not Recruiting
Active Not RecruitingNCT04339452
Impella Supported OPCABG
Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: a Single Center Prospective Observational Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Lucian Archambault Durham III · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Impella 5.5 with SmartAssist Supported OPCABG | Subjects will undergo insertion of an axillary or ascending aortic Impella 5.5 with SmartAssist, followed by Impella-supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection. |
Timeline
- Start date
- 2022-05-11
- Primary completion
- 2025-12-01
- Completion
- 2026-03-01
- First posted
- 2020-04-09
- Last updated
- 2025-01-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04339452. Inclusion in this directory is not an endorsement.