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Clinical Trials/NL-OMON42831
NL-OMON42831
Not Yet Recruiting
N/A

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

St. Jude Medical0 sites15 target enrollmentTBD
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
St. Jude Medical
Enrollment
15
Status
Not Yet Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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