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Cerebral Protection Device

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR Trial)

N/A
Waitlist Available
Led By Samir Kapadia, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up <=72 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial shows that using the Sentinel® Cerebral Protection System during TAVR significantly reduces the risk of peri-procedural stroke.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~<=72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and <=72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TAVR with SentinelExperimental Treatment1 Intervention
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Group II: TAVR without SentinelActive Control1 Intervention
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel® Cerebral Protection System
2020
N/A
~3000

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
854,989 Total Patients Enrolled
11 Trials studying Stroke
8,839 Patients Enrolled for Stroke
Samir Kapadia, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
1,013 Total Patients Enrolled
~507 spots leftby Jan 2026
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