Safety and Technical Performance Evaluation of the Emboliner Embolic Protection Device: A New Zealand Experience
- Conditions
- Transcatheter aortic valve replacementEmbolic protectionCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12622000473763
- Lead Sponsor
- Emboline, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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.
Subject has hypertrophic cardiomyopathy with or without obstruction.
Subject has severe ventricular dysfunction.
Subject has echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
Subject has an active infection.
Subject has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 months; or subject has symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting.
Subject presents with renal failure at the time of screening.
Subject has a planned treatment with any other investigational device or procedure during the study period.
Subject has undergone balloon valvuloplasty (BAV) within the established period prior to treatment.
Subject is planning to undergo any other cardiac surgical or interventional procedure.
Subject has a need for emergency surgery.
Subject is pregnant or nursing, or subject intends to become pregnant during the term of the study.
Subject is unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment; or who are unable to comprehend English.
The investigator considers participation in the study to not be in the subject’s best interest.
Subject presents with anatomical limitations precluding the use of the investigational device.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of 30-day MACCE, as defined as the composite of all death, all stroke, or stage 3 acute kidney injury (at discharge or 72 hours post index procedure.<br>MACCE is an acronym for Major Adverse Cardiovascular and Cerebrovascular Event.<br><br>These data will be collected through a review of medical records, audit of study records, patient follow-up, and protocol required evaluations. [Safety to 30 days post procedure.];Technical performance (technical success) will be defined as the ability to successfully access the aortic arch with successful Emboliner positioning followed by retrieval from the study subject. <br><br>These criteria will be assessed by the operating physician as well as the angiographic core laboratory using imaging provided for analysis. <br>[Performance endpoint immediately post procedure.]
- Secondary Outcome Measures
Name Time Method Incidence of investigational device related serious adverse events to 30 days.<br><br>Examples of such adverse events are as follows:<br> - Access site complication such as swelling (edema)<br> - Pain/sore/tender at access site<br> - Ischemic stroke or transient ischemic attack (TIA)<br> - Thrombus formation<br> - Embolism<br><br>All adverse events regardless of relationship to the study device will be reported. AEs will be identified through patient follow up care, clinical examination, review of medical records and/or any other mechanism by which an adverse event is noted. [Follow up will be at 30 days post procedure. This outcome will be assessed at the 30-day post treatment timepoint.]