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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04149535
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019
Date last updated
10/05/2021

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) - All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge
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
Gender
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
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
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Denmark
State/province [24] 0 0
Aarhus
Country [25] 0 0
Denmark
State/province [25] 0 0
København
Country [26] 0 0
France
State/province [26] 0 0
Marseille
Country [27] 0 0
France
State/province [27] 0 0
Toulouse
Country [28] 0 0
Germany
State/province [28] 0 0
Bad Segeberg
Country [29] 0 0
Germany
State/province [29] 0 0
Dresden
Country [30] 0 0
Germany
State/province [30] 0 0
Münich
Country [31] 0 0
Germany
State/province [31] 0 0
Ulm

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

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04149535
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
Peyton Willert
Address 0 0
Country 0 0
Phone 0 0
707-528-9300
Fax 0 0
Email 0 0
peyton.willert@bsci.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04149535