StrokePROTECTED TAVRNCT04149535

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

A study testing Sentinel® Cerebral Protection System in people with Stroke, run by Boston Scientific Corporation at 57 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Any age
Conditions the study is for: Stroke
What is being tested?: Sentinel® Cerebral Protection System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,000 participants
Where: 57 sitesin 6 countries
Study dates: 7 Feb 2020to 1 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

57 sites in 6 countries.

Country

City, postcode or hospital

57 sites in 6 countries

United States41 sites

Piedmont Hosptial
Atlanta, Georgia, 30309
Heart Hospital of Austin
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kaleida Health
Buffalo, New York, 14213
Lahey Clinic Hospital
Burlington, Massachusetts, 01805
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor Heart and Vascular
Dallas, Texas, 75226
Mercy Hospital Medical Center
Des Moines, Iowa, 50314
Englewood Medical Center
Englewood, New Jersey, 07631
Hartford Hospital
Hartford, Connecticut, 06102
The Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Research Medical Center
Kansas City, Missouri, 64132
Sparrow Hospital
Lansing, Michigan, 48912
South Denver Cardiology Associates PC and Swedish medical center
Littleton, Colorado, 80120
Cedars Sinai Medical Center
Los Angeles, California, 90048
North Shore University Hospital
Manhasset, New York, 11030
Wellstar
Marietta, Georgia, 30060
Baptist Memorial
Memphis, Tennessee, 38120
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
NYU Winthrop
Mineola, New York, 11501
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Community Munster
Munster, Indiana, 46321
Centennial Medical Center
Nashville, Tennessee, 37203
Vanderbilt
Nashville, Tennessee, 37323
Jersey Shore University Medical Center
Neptune City, New Jersey, 98374
Creighton - Bergan Cardiology
Omaha, Nebraska, 68124
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Oregon Health Sciences University
Portland, Oregon, 97239
Baylor Scott and White
Round Rock, Texas, 78665
University of California, Davis Medical Center
Sacramento, California, 95817
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, 78229
Kaiser Foundation Hospital - San Francisco
San Francisco, California, 94118
Intercoastal Medical Group
Sarasota, Florida, 34239
St. Johns Hospital
Springfield, Illinois, 62701
Tampa General Hospital
Tampa, Florida, 33606
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Tucson Medical Center
Tucson, Arizona, 85712
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Lankenau
Wynnewood, Pennsylvania, 19096

Other trials in United States

Germany6 sites

Heart Center Leipzig
Bad Segeberg, 23795
Herzzentrum Dresden GmbH
Dresden, D-01307
University Hospital Frankfurt
Frankfurt, 60590
Universitaetsklinikum Schleswig-Holstein
Lübeck, D-23538
LMU Klinikum der Universität München
Münich, 81377
Universitaetsklinikum Ulm
Ulm, 89081

Other trials in Germany

Denmark3 sites

Aarhus University Hospital
Aarhus, 8200
Aarhus University Hospital
Aarhus, DK-8200
Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

Italy3 sites

Maria Cecilia Hospital SPA
Cotignola, 48010
Fondazione Centro San Raffaele
Milan, 20132
Policlinico San Donato
San Donato, Milanese, 20097

Other trials in Italy

Australia2 sites

The Prince Charles Hospital
Chermside, 4032
Monash Medical Center
Clayton, Victoria, 3168

Other trials in Australia

France2 sites

CHU La Timone Hospital
Marseille, 13005
Clinique Pasteur
Toulouse, 31076

Other trials in France

About this study

Official title: 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).

Conditions: Stroke
Being tested: Sentinel® Cerebral Protection System
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sentinel® Cerebral Protection SystemDevice
cerebral embolic protection system

Study groups in NCT04149535
Study group	Role	What they receive
TAVR with Sentinel	Experimental	Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System. Receives: Device: Sentinel® Cerebral Protection System
TAVR without Sentinel	No intervention	Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: <=72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 20201 Feb 2022

First posted4 Nov 2019
Study start7 Feb 2020
Primary completion1 Feb 2022
Study completion1 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04149535
Sponsor's protocol ID: S2453
Acronym: PROTECTED TAVR
Status last verified: Jan 2023
First submitted: 31 Oct 2019
Last updated: 2 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: 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)

Publications

Makkar RR, Gupta A, Waggoner TE, Horr S, Karha J, Satler L, Stoler RC, Alvarez J, Sakhuja R, MacDonald L, Modolo R, Leon MB, Linke A, Kapadia SR. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):17-24. doi: 10.1001/jamacardio.2024.4278.
PubMed 39471309
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.
PubMed 36121045

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
ClinicalTrials.gov ID: NCT04149535
Acronym / sponsor ID: PROTECTED TAVR / S2453
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,000 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 7 Feb 2020 (actual)
Primary completion: 1 Feb 2022 (actual)
Study completion: 1 Feb 2022 (actual)
First posted: 4 Nov 2019 (actual)
Results: Posted 2 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TAVR with Sentinel	Experimental	Device: Sentinel® Cerebral Protection SystemPatients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
TAVR without Sentinel	No intervention	–Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sentinel® Cerebral Protection Systemcerebral embolic protection system	Device	TAVR with Sentinel

Primary outcome

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.

Results and safety

Results posted to the registry on 2 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAVR With Sentinel	1,501	1,472
TAVR Without Sentinel	1,499	1,481

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

Time frame: <=72 hours. Count of participants. Unit: Participants

Measure	TAVR With Sentinel n = 1501	TAVR Without Sentinel n = 1499
Value	34	43

Population analysed: Intent-to-Treat

Adverse events

Time frame: Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAVR With Sentinel	285 of 1,501 (19%)	0 of 1,501 (0%)	11 of 1,501
TAVR Without Sentinel	315 of 1,499 (21%)	0 of 1,499 (0%)	7 of 1,499

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39471309Makkar RR, Gupta A, Waggoner TE, Horr S, Karha J, Satler L, Stoler RC, Alvarez J, Sakhuja R, MacDonald L, Modolo R, Leon MB, Linke A, Kapadia SR. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):17-24. doi: 10.1001/jamacardio.2024.4278.
Derived from this study: PubMed 36121045Kapadia 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.
Individual participant dataSharing planned: Undecided. 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)

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
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Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samir Kapadia, MD principal investigator

The Cleveland Clinic

57 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sentinel® Cerebral Protection System in people with Stroke, run by Boston Scientific Corporation at 57 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Denmark, Italy, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) (time frame: <=72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04149535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.