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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
Date last updated
2/02/2023

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
Not applicable
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
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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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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Minnesota
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Missouri
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Nebraska
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New Jersey
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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
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Wisconsin
Country [25] 0 0
Denmark
State/province [25] 0 0
Aarhus
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Denmark
State/province [26] 0 0
København
Country [27] 0 0
France
State/province [27] 0 0
Marseille
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France
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Toulouse
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Germany
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Bad Segeberg
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Lübeck
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Germany
State/province [33] 0 0
Münich
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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
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/study/NCT04149535
Trial related presentations / publications
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.
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



Summary Results

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