PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Purpose
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
Condition
- Stroke
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access - Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery. - Subject (or legal representative) provides written informed consent.
Exclusion Criteria
- Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery. - Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium. - Subject has compromised blood flow to the right upper extremity. - Subject has access vessels with excessive tortuosity. - Subject has uncorrected bleeding disorders. - Subject is contraindicated for anticoagulant and antiplatelet therapy.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TAVR with Sentinel |
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. |
|
|
No Intervention TAVR without Sentinel |
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System. |
|
More Details
- Status
- Completed
- Sponsor
- Boston Scientific Corporation