Active — Not RecruitingNot Applicable

Impella Supported OPCABG

United States30 participantsStarted 2022-05-11

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Intraoperative hemodynamic stability

Timeframe: Intraoperative

Trial details

NCT IDNCT04339452

SponsorLucian Archambault Durham III

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Ischemic Cardiomyopathy trials