None listed
Conditions
Brief summary
Cerebral embolism is a known complication of cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, and electrophysiology procedures, Embolic particles, which may include thrombus, valvular tissue, and foreign material, may become dislodged by surgical or catheter manipulations and enter the bloodstream. Cerebral embolism can lead to neurological and neurocognitive deficits, stroke, or death. The accumulation of subclinical lesions is associated with increased risk of dementia and reduced resistance to future brain insult. Other organs downstream can also be damaged by embolism, resulting in diminished function or organ failure. These risks are especially critical in percutaneous heart valve therapies (PHVT), such as transcatheter aortic valve replacement (TAVR). New white matter brain lesions have been noted using MRI in about 70-95% of TAVR patients following the procedure, indicating high risks of long-term ischemic damage. Furthermore, when TAVR is performed with a cerebral embolic protection device, debris is captured in up to 99% of the patients with captured particles as large as 2 mm in size. The use of embolic protection devices has been shown to significantly reduce the volume of new ischemic lesions in TAVR patients. Further, their use significantly reduces the incidence of peri-procedural strokes during TAVR.
Interventions
The Emboliner system consists of a single-use, sterile, heparin-coated Nitinol filter attached to a catheter and its associated delivery system. The Emboliner is introduced through a femoral access site using the provided custom delivery sheath. In TAVR procedures, the contralateral access site is used. The filter of the Emboliner is deployed across the aortic arch to prevent embolic debris generated during the procedure from reaching the cerebral circulation and other vulnerable areas of the bo
The Emboliner system consists of a single-use, sterile, heparin-coated Nitinol filter attached to a catheter and its associated delivery system. The Emboliner is introduced through a femoral access site using the provided custom delivery sheath. In TAVR procedures, the contralateral access site is used. The filter of the Emboliner is deployed across the aortic arch to prevent embolic debris 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. 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. The Emboliner addresses the limitations of the current technologies with the following unique features: • Circumferential coverage: intended to cover all cerebral branch vessels with less positional sensitivity than embolic deflecting panels • Closed downstream end: captures and removes both cerebral and non-cerebral embolic debris • Integrated lumen: allows device deployment via the typical angiographic pigtail access site used in a TAVR procedure with no additional procedural access required • Expandable access port: allows easy passage of procedural devices (e.g., TAVR delivery systems) through the Emboliner filter while maintaining complete embolic protection • Catheter-based device: provides ease-of-use and active control of the filter throughout the procedure (consistent with typical cardiology procedural tools) for adaptability (ease of learning curve) Operation and treatment with the device, to include device deployment, device insertion, deployment duration, and device removal, will be performed by trained device operators, to include the study principal investigator, and all sub-investigator’s delegated device operation responsibilities. Prior to the index procedure, patients requiring transcatheter aortic valve replacement will be evaluated for study participation. If they appear to meet inclusion criteria, and consent to screening, they will be evaluated for study eligibility. Following the TAVR procedure, the Emboliner system will be removed immediately after the operation. Use of the Emboliner device is expected to add approximately 15-20 minutes to the overall TAVR procedure. Actual timing of procedure will be followed and documented. All study cases will undergo review for compliance through the study monitoring process.
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
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. 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.
Outcome results
None listed