HeartMate PHP™ CE Mark Clinical Investigation Plan
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- High Risk Percutaneous Coronary Intervention
- Sponsor
- Abbott Medical Devices
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Primary Endpoint
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.
Detailed Description
The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age.
- •Patient presents with a non-emergent need for complex PCI with:
- •an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
- •the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
- •Written, signed, and dated informed consent
Exclusion Criteria
- •Emergent PCI
- •ST elevation myocardial infarction within 7 days of procedure
- •Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- •Hemodynamic support with the HeartMate PHP post-PCI is anticipated
- •Cardiogenic shock (SBP \<90 mmHg for \>1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index \<2.2 L/min/m2)
- •Mural thrombus in the left ventricle
- •History of aortic valve replacement
- •Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
- •Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
- •Severe peripheral vascular disease
Outcomes
Primary Outcomes
Primary Endpoint
Time Frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Primary Performance Endpoint: Freedom from hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required. Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure
Composite of Major Adverse Events (MAE)
Time Frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Primary Safety Endpoint: Composite of Major Adverse Events (MAE): * device-related cardiac death, * new Q wave myocardial infarction, * surgical intervention due to device complication or malfunction, * device-related access site complication requiring intervention or device-related limb ischemia, * cerebral vascular accident (CVA), * new or worsening aortic valve insufficiency, * major bleeding complication (BARC 3 or \>), * severe hypotension Primary Endpoint will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure
Secondary Outcomes
- Secondary Endpoint(Post procedure or at hospital discharge (whichever is longer), 30 days post procedure)
- Major Adverse Event Composites(Post procedure or at hospital discharge (whichever is longer), 30 days post procedure)