The PROTEMBO Trial

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Cerebral Protection in Transcatheter Aortic Valve Replacement: the PROTEMBO Trial

The PROTEMBO Trial

Condition
Severe Aortic Valve Stenosis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Clearwater

BayCare Health System / Morton Plant Hospital, Clearwater, Florida, United States, 33756

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Kansas City

Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States, 64111

St Louis

Washington University - St. Louis, St Louis, Missouri, United States, 63110

Buffalo

State University of New York at Buffalo, Buffalo, New York, United States, 14203

New York City

NYU Langone, New York City, New York, United States, 10016

New York City

Mount Sinai Hospital, New York City, New York, United States, 10029

New York

Columbia University Medical Center / NYPH, New York, New York, United States, 10032

New York

Weill Medical College / Cornell University, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. The heart team recommends transcatheter aortic valve replacement via femoral access consistent with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
  • 2. The subject and the treating physician agree that the subject will undergo the scheduled pre procedural testing and return for all required post procedure follow up visits.
  • 3. The subject is able to provide informed consent, has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the relevant regulatory authority of the respective clinical site.
  • 4. Subject is a minimum of 18 years of age.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Protembis GmbH,

Roxana Mehran, MD, STUDY_CHAIR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-07