St. Jude Medical HeartMate® PHP CE Mark Post Approval Study

• Conditions: stent placement; procedure of heart arteries; 10011082

• Registration Number: NL-OMON42831
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

* At least 18 years of age.
* Patient presents with a non-emergent need for complex PCI and in the opinion of the investigator is a risk of hemodynamic compromise during PCI.
* 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
*Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
*Serum creatinine > 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified