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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sentinel® Cerebral Protection System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tucson Medical Center
  • Cedars Sinai Medical Center
  • University of California, Davis Medical Center
  • Kaiser Foundation Hospital - San Francisco
  • Los Robles Regional Medical Center
  • South Denver Cardiology Associates PC and Swedish medical center
  • Hartford Hospital
  • Medstar Washington Hospital Center
  • Intercoastal Medical Group
  • Tampa General Hospital
  • Piedmont Hosptial
  • Wellstar
  • St. Johns Hospital
  • Community Munster
  • Mercy Hospital Medical Center
  • University of Iowa Hospitals and Clinics
  • Massachusetts General Hospital
  • Lahey Clinic Hospital
  • Sparrow Hospital
  • Abbott Northwestern Hospital
  • Research Medical Center
  • Creighton - Bergan Cardiology
  • Englewood Medical Center
  • Jersey Shore University Medical Center
  • Kaleida Health
  • North Shore University Hospital
  • NYU Winthrop
  • Wake Forest University School of Medicine
  • Cleveland Clinic Foundation
  • Oregon Health Sciences University
  • Lankenau
  • Baptist Memorial
  • Centennial Medical Center
  • Vanderbilt
  • Heart Hospital of Austin
  • Baylor Heart and Vascular
  • The Methodist Hospital
  • The Heart Hospital Baylor Plano
  • Baylor Scott and White
  • Methodist Healthcare System of San Antonio dba Methodist Hospital
  • Aurora St. Luke's Medical Center
  • Monash Medical Center
  • The Prince Charles Hospital
  • Aarhus University Hospital
  • Aarhus University Hospital
  • Rigshospitalet
  • CHU La Timone Hospital
  • Clinique Pasteur
  • Heart Center Leipzig
  • Herzzentrum Dresden GmbH
  • University Hospital Frankfurt
  • Universitaetsklinikum Schleswig-Holstein
  • LMU Klinikum der Universität München
  • Universitaetsklinikum Ulm
  • Policlinico San Donato
  • Maria Cecilia Hospital SPA
  • Fondazione Centro San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAVR with Sentinel

TAVR without Sentinel

Arm Description

Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.

Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.

Outcomes

Primary Outcome Measures

The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2019
Last Updated
January 17, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04149535
Brief Title
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Acronym
PROTECTED TAVR
Official Title
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAVR with Sentinel
Arm Type
Experimental
Arm Description
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Arm Title
TAVR without Sentinel
Arm Type
No Intervention
Arm Description
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Intervention Type
Device
Intervention Name(s)
Sentinel® Cerebral Protection System
Intervention Description
cerebral embolic protection system
Primary Outcome Measure Information:
Title
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
Description
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.
Time Frame
<=72 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Foundation Hospital - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Los Robles Regional Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
South Denver Cardiology Associates PC and Swedish medical center
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Intercoastal Medical Group
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Piedmont Hosptial
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Wellstar
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
St. Johns Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Community Munster
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Mercy Hospital Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Lahey Clinic Hospital
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Creighton - Bergan Cardiology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Englewood Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
98374
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14213
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Winthrop
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lankenau
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Baptist Memorial
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37323
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Heart and Vascular
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Baylor Scott and White
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Facility Name
Methodist Healthcare System of San Antonio dba Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Monash Medical Center
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
CHU La Timone Hospital
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Heart Center Leipzig
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Herzzentrum Dresden GmbH
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
LMU Klinikum der Universität München
City
Münich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Policlinico San Donato
City
San Donato
State/Province
Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
Maria Cecilia Hospital SPA
City
Cotignola
ZIP/Postal Code
48010
Country
Italy
Facility Name
Fondazione Centro San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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)
Citations:
PubMed Identifier
36121045
Citation
Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messe SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022 Oct 6;387(14):1253-1263. doi: 10.1056/NEJMoa2204961. Epub 2022 Sep 17.
Results Reference
derived

Learn more about this trial

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

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