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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04149535




Registration number
NCT04149535
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019

Titles & IDs
Public title
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Scientific title
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
Secondary ID [1] 0 0
S2453
Universal Trial Number (UTN)
Trial acronym
PROTECTED TAVR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sentinel® Cerebral Protection System

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

No intervention: TAVR without Sentinel - Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.


Treatment: Devices: Sentinel® Cerebral Protection System
cerebral embolic protection system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
Timepoint [1] 0 0
<=72 hours

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2022
Sample size
Target
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Center - Clayton
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
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United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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Nebraska
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [20] 0 0
United States of America
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Oregon
Country [21] 0 0
United States of America
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Pennsylvania
Country [22] 0 0
United States of America
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Tennessee
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United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Denmark
State/province [25] 0 0
Aarhus
Country [26] 0 0
Denmark
State/province [26] 0 0
København
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
Germany
State/province [29] 0 0
Bad Segeberg
Country [30] 0 0
Germany
State/province [30] 0 0
Dresden
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Germany
State/province [31] 0 0
Frankfurt
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Germany
State/province [32] 0 0
Lübeck
Country [33] 0 0
Germany
State/province [33] 0 0
Münich
Country [34] 0 0
Germany
State/province [34] 0 0
Ulm
Country [35] 0 0
Italy
State/province [35] 0 0
Milanese
Country [36] 0 0
Italy
State/province [36] 0 0
Cotignola
Country [37] 0 0
Italy
State/province [37] 0 0
Milan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Samir Kapadia, MD
Address 0 0
The Cleveland Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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)


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04149535