MedTrace Logo

The PROTEMBO Trial

NCT05873816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Severe Aortic Valve Stenosis

Interventions

DEVICE

ProtEmbo - Cerebral Embolic Protection

Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.

DEVICE

Sentinel - Cerebral Embolic Protection

Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.

Sponsors & Collaborators

  • Protembis GmbH

    lead INDUSTRY

Principal Investigators

  • Roxana Mehran, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2025-10-18
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873816 on ClinicalTrials.gov