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

October 13, 2022 updated by: Boston Scientific Corporation

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Chermside, Australia, 4032
        • The Prince Charles Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Center
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Aarhus, Denmark, DK-8200
        • Aarhus University Hospital
      • København, Denmark, 2100
        • Rigshospitalet
  • France
      • Marseille, France, 13005
        • CHU La Timone Hospital
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • Bad Segeberg, Germany, 23795
        • Heart Center Leipzig
      • Dresden, Germany, D-01307
        • Herzzentrum Dresden GmbH
      • Frankfurt, Germany, 60590
        • University Hospital Frankfurt
      • Lübeck, Germany, D-23538
        • Universitaetsklinikum Schleswig-Holstein
      • Münich, Germany, 81377
        • LMU Klinikum der Universität München
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Italy
      • Cotignola, Italy, 48010
        • Maria Cecilia Hospital SPA
      • Milan, Italy, 20132
        • Fondazione Centro San Raffaele
    • Milanese
      • San Donato, Milanese, Italy, 20097
        • Policlinico San Donato
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Tucson Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital - San Francisco
      • Thousand Oaks, California, United States, 91360
        • Los Robles Regional Medical Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates PC and Swedish medical center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Sarasota, Florida, United States, 34239
        • Intercoastal Medical Group
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hosptial
      • Marietta, Georgia, United States, 30060
        • Wellstar
    • Illinois
      • Springfield, Illinois, United States, 62701
        • St. Johns Hospital
    • Indiana
      • Munster, Indiana, United States, 46321
        • Community Munster
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Hospital Medical Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Hospital
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Creighton - Bergan Cardiology
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Medical Center
      • Neptune, New Jersey, United States, 98374
        • Jersey Shore University Medical Center
    • New York
      • Buffalo, New York, United States, 14213
        • Kaleida Health
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Mineola, New York, United States, 11501
        • NYU Winthrop
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
      • Nashville, Tennessee, United States, 37323
        • Vanderbilt
    • Texas
      • Austin, Texas, United States, 78705
        • Heart Hospital of Austin
      • Dallas, Texas, United States, 75226
        • Baylor Heart and Vascular
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
      • Round Rock, Texas, United States, 78665
        • Baylor Scott and White
      • San Antonio, Texas, United States, 78229
        • Methodist Healthcare System of San Antonio dba Methodist Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
  • Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
  • Subject (or legal representative) provides written informed consent.

Exclusion Criteria:

  • Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
  • Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
  • Subject has compromised blood flow to the right upper extremity.
  • Subject has access vessels with excessive tortuosity.
  • Subject has uncorrected bleeding disorders.
  • Subject is contraindicated for anticoagulant and antiplatelet therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAVR with Sentinel
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Device: Sentinel® Cerebral Protection System
cerebral embolic protection system
No Intervention: TAVR without Sentinel
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of stroke through 72 hours post TAVR procedure or discharge (whichever comes first)
Time Frame: <=72 hours
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
<=72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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