ACTRN12622000473763
Recruiting
N/A
Safety and Technical Performance Evaluation of the Emboliner Embolic Protection Device: A New Zealand Experience
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Transcatheter aortic valve replacement
- Sponsor
- Emboline, Inc.
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject must present with symptomatic severe aortic stenosis and be eligible for treatment with either an Edwards Sapien or Medtronic Evolut valve and corresponding TAVR procedure according to current guidelines and have consented to the TAVR procedure.
- •The subject and the treating physician agree that the subject will return for required post\-procedure follow\-up visit.
- •The subject or the subject's legal representative has been informed of the nature of the trial, has agreed to its provisions, and has provided written informed consent as approved by the IRB/EC of the respective clinical site.
- •The subject must be 18 years or older at the time of consent.
Exclusion Criteria
- •Subject is not undergoing TAVR via the trans\-femoral route.
- •Subject has severe allergy or contraindication to aspirin, heparin, bivalirudin, clopidogrel, and/or contrast sensitivity that cannot be adequately controlled.
- •Subject has uncorrected bleeding disorder.
- •Subject has hypercoagulable states that cannot be corrected.
- •Subject has known diagnosis of acute myocardial infarction (AMI) within the established study period.
- •Subject has a history of substance abuse that may cause non\-compliance with the protocol or confound the data interpretation.
- •Subject presents with cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension at the time of screening.
- •Subject has a history of a stroke or transient ischemic attack (TIA) within the established study period.
- •Subject's valve/valve disease is not indicated for use with the Emboliner System.
- •Subject has blood dyscrasias.
Outcomes
Primary Outcomes
Not specified
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