The primary objective for this early feasibility study is to assess safety and feasibility of the Impella ECP device in adult patients undergoing an elective high-risk percutaneous coronary intervention. To assess safety, special attention is being paid to the effect of the pump on the aortic valve
Impella ECP
Use of the Impella ECPTM in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study
Heart disease
All genders
18-80
Recruiting now
Overview
Principal Investigator: Navin Kapur, MD
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Vilma Castaneda, MD
Study details
Inclusion Criteria
- Scheduled for an elective high-risk percutaneous coronary intervention with hemodynamic support
Exclusion Criteria
- Infection of the proposed procedural access site or suspected systemic active infection, including any fever.
- Any contraindication that precludes placing an Impella<sup>®</sup>-Study device
- Structural aortic valve regurgitation or stenosis (anatomic abnormalities)
Study Requirements
There will be only screening visit, procedure visit and a 30 d follow up. Clinical evaluation, Blood test abut 3-4 teaspoons will be collected on each visit for routine tests, electrocardiography, echocardiography ( ultrasound test on your chest). After the 30 d visit the subject will be out of the study.