← Back to Search

ProtEmbo - Cerebral Embolic Protection for Aortic Stenosis

N/A
Recruiting
Research Sponsored by Protembis GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 ±12 hours post tavr procedure
Awards & highlights
No Placebo-Only Group

Summary

The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.

Eligible Conditions
  • Aortic Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 ±12 hours post tavr procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 ±12 hours post tavr procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MACCE at 30 days
Total new lesion volume

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ProtEmbo - Cerebral Embolic ProtectionExperimental Treatment1 Intervention
Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.
Group II: Sentinel - Cerebral Embolic ProtectionActive Control1 Intervention
Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.
Group III: Control ArmActive Control1 Intervention
Subjects will undergo TAVR without embolic protection.

Find a Location

Who is running the clinical trial?

Protembis GmbHLead Sponsor
2 Previous Clinical Trials
69 Total Patients Enrolled
Roxana Mehran, MDStudy ChairIcahn School of Medicine at Mount Sinai
16 Previous Clinical Trials
42,584 Total Patients Enrolled
~250 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top