None listed
Conditions
Brief summary
A known complication of TAVR and similar procedures is the dislodging of embolic particles. Those particles may include blood clot, valvular tissue, or foreign material such as calcium. Once these particles have entered the bloodstream, it is possible that they might travel to the brain and cause neurological problems or stroke; or they may travel to other parts of the body, such as the kidneys, and cause damage; or they may lead to death. The device being investigated in this study, the Emboliner embolic protection catheter, is a temporarily-implanted aortic embolic filter for use during cardiology interventions. The filter of the Emboliner is intended to stop these dislodged particles (embolic particles) from entering the bloodstream and travelling to other parts of the body. It is made of a metal called nitinol and is coated with a medication (heparin) that helps to prevent blood clotting on the device. The Emboliner is positioned in the aorta and is expanded so that it fits snuggly against the wall of the aorta. It is designed to filter the blood and capture any embolic particles. The device is then able to be retrieved and removed from the body, along with any embolic particles that may have been collected. The objective of study is to evaluate the safety and performance of the Embo-liner embolic protection catheter.
Interventions
The EmbolinerTM embolic protection catheter, manufactured by Emboline, Inc., is a temporarily-implanted aortic embolic filter for use during interventional cardiology procedures, such as transcatheter aortic valve replacement (TAVR). The Emboliner system consists of a single-use, sterile, heparin-coated Nitinol filter attached to a catheter, a delivery/retrieval sheath and dilator, a peelaway inserter, and a braid loading tool. The Emboliner is introduced through a femoral access site using the
The EmbolinerTM embolic protection catheter, manufactured by Emboline, Inc., is a temporarily-implanted aortic embolic filter for use during interventional cardiology procedures, such as transcatheter aortic valve replacement (TAVR). The Emboliner system consists of a single-use, sterile, heparin-coated Nitinol filter attached to a catheter, a delivery/retrieval sheath and dilator, a peelaway inserter, and a braid loading tool. The Emboliner is introduced through a femoral access site using the included delivery sheath and dilator. In TAVR procedures, the contralateral access site is used. The filter of the Emboliner is deployed across the aortic arch to prevent embolic debris that are generated during the procedure from reaching the cerebral circulation, and other vulnerable areas of the body. The integrated 6-Fr compatible lumen of the Emboliner catheter allows guidewires and diagnostic catheters to be introduced through the Emboliner during the procedure. The expandable access port of the Emboliner allows passage of catheters and delivery systems through the filter during the procedure. The use of the Emboliner device is expected to add minimal time to the overall TAVR procedure (approximately 15-30 minutes). The Emboliner device is used by the interventionalist performing the TAVR Procedure. At the end of the interventional procedure, the Emboliner is retrieved by withdrawal into the delivery/retrieval sheath, which is then removed from the body.
Sponsors
Emboline, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must be 18 years and older 2. The patient must be a candidate for TAVR according 3. The patient has been provided written informed consent
Exclusion criteria
1. Patients with an ascending aortic diameter [that meets the requirements of product labeling] 2. Patients with the linear distance from the femoral access site to the aortic valve root [per product labeling] 3. Patients not undergoing TAVR via the trans-femoral route. 4. Patients that are contraindicated for anticoagulant and/or antiplatelet therapy or uncorrected bleeding disorder. 5. Pregnant or nursing subjects, or subjects who intend to become pregnant during the term of the study. 6. Patients with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure. 7. Patients with known other mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year. 8. Patients with severe allergy to study materials or required medication that cannot be adequately pre-medicated or adequately controlled. 9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months. 10. Patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months. 11. Patients with renal failure. 12. Patients presenting with cardiogenic shock or severe hypotension. 13. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access, or whose vascular anatomy is unable to accommodate the access sheath. 14. Patients who have a planned treatment with any other investigational device or procedure during the study period. 15. Patients planned to undergo any other cardiac surgical or interventional procedure within two (2) weeks prior to the TAVR procedure, or 30 days after the TAVR procedure. 16. Patients with aortic implant or other abnormality (e.g., asymmetrical or sharp aortic calcifications). 17. Emergency patients.
Outcome results
None listed