N/A
N=3,000
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04149535 ↗Enrolled (actual)
3,000
Serious AEs
20.0%
Results posted
Feb 2023
Primary outcome: Primary: The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) — 34; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sentinel® Cerebral Protection System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) |
34; 43 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04149535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.