Coronary sclerosis high-risk PCI
Conditions
Interventions
The HeartMate PHP system is a catheter-based heart pump and console designed to
provide hemodynamic left ventricular support during intraprocedural use to
maintain adequate systemic cardiac output.
Sponsors
Thoratec Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - At least 18 years of age. - Patient presents with a non-emergent need for complex PCI with: 1) an ejection fraction of
Exclusion criteria
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 1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index 3.5mg/dL within 7 days of procedure - Liver dysfunction with elevation of liver enzymes and bilirubin levels to >= 3x ULN or INR (Internationalized Normalized Ratio) >= 2 - Uncorrectable abnormal coagulation parameters - Active systemic infection requiring treatment with antibiotics - Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction - Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs - History of heparin induced thrombocytopenia. - Patient is pregnant or planning to become pregnant during the study period - Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 1) Efficacy of hemodynamic support as measured by: * Maximal decrease in cardiac power output (CPO) from baseline * Changes in central venous pressure from baseline (CVP) * Changes in pulmonary artery pressure from baseline (PAP) * Changes in pulmonary capillary wedge pressure from baseline (PCWP) * Changes in cardiac output from baseline (CO) * Changes in cardiac index from baseline (CI) 2) Individual components of the Major Adverse Event Composites Secondary Endpoints will be evaluated at: * Post procedure or at hospital discharge (whichever is longer) * 30 days post procedure | — |
Countries
Netherlands
Outcome results
None listed