COMPLETED

The PROTEMBO Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Cerebral Protection in Transcatheter Aortic Valve Replacement: The PROTEMBO Trial

Quick Facts

Study Start:2024-03-21
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05873816

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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. 4. Subject is a minimum of 18 years of age.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Tucson Medical Center Health
Tucson, Arizona, 85712
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
BayCare Health System / Morton Plant Hospital
Clearwater, Florida, 33756
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Washington University - St. Louis
St Louis, Missouri, 63110
United States
Morristown Medical Center
Morristown, New Jersey, 07690
United States
State University of New York at Buffalo
Buffalo, New York, 14203
United States
NYU Langone
New York, New York, 10016
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University Medical Center / NYPH
New York, New York, 10032
United States
Weill Medical College / Cornell University
New York, New York, 10065
United States
University of Texas, Memorial Hermann Hospital
Houston, Texas, 77030
United States
University of Virginia, Charlottesville
Charlottesville, Virginia, 22908
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Protembis GmbH

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-21
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • TAVR
  • Cerebral embolic protection

Additional Relevant MeSH Terms

  • Severe Aortic Valve Stenosis