Trial · NCT04149535

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

NCT04149535, Not applicable, Completed, Boston Scientific Corporation; results first posted 2023-02-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement. Trials, record NCT04149535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04149535

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
NCT number: NCT04149535
Status: Completed
Phases: Not applicable
Enrollment: 3,000 participants, actual
Lead sponsor: Boston Scientific Corporation
Conditions: Stroke
Interventions: Sentinel® Cerebral Protection System
First posted: 2019-11-04
Last updated: 2023-02-02
Results first posted: 2023-02-02

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	<=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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	<=72 hours	Intent-to-Treat	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	TAVR With Sentinel		34		Participants
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	TAVR Without Sentinel		43		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TAVR With Sentinel	1,501
Overall Study	STARTED	TAVR Without Sentinel	1,499
Overall Study	COMPLETED	TAVR With Sentinel	1,472
Overall Study	COMPLETED	TAVR Without Sentinel	1,481
Overall Study	NOT COMPLETED	TAVR With Sentinel	29
Overall Study	NOT COMPLETED	TAVR Without Sentinel	18

Source ClinicalTrials.gov

Adverse events334

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Atrioventricular block complete	Cardiac disorders	TAVR With Sentinel	86	1,501
serious	Atrioventricular block complete	Cardiac disorders	TAVR Without Sentinel	92	1,499
serious	Bundle branch block left	Cardiac disorders	TAVR With Sentinel	41	1,501
serious	Bundle branch block left	Cardiac disorders	TAVR Without Sentinel	29	1,499
serious	Atrial fibrillation	Cardiac disorders	TAVR With Sentinel	15	1,501
serious	Atrial fibrillation	Cardiac disorders	TAVR Without Sentinel	14	1,499
serious	Pericardial effusion	Cardiac disorders	TAVR With Sentinel	8	1,501
serious	Pericardial effusion	Cardiac disorders	TAVR Without Sentinel	6	1,499
serious	Atrioventricular block second degree	Cardiac disorders	TAVR With Sentinel	7	1,501
serious	Atrioventricular block second degree	Cardiac disorders	TAVR Without Sentinel	6	1,499

1 to 10 of 334Source ClinicalTrials.gov

See all 334 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAVR With Sentinel	11	1,501
Total, all-cause mortality	TAVR Without Sentinel	7	1,499
Total, other adverse events	TAVR With Sentinel	0	1,501
Total, other adverse events	TAVR Without Sentinel	0	1,499
Total, serious adverse events	TAVR With Sentinel	285	1,501
Total, serious adverse events	TAVR Without Sentinel	315	1,499

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36121045	DERIVED	PubMed
39471309	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TAVR With Sentinel vs TAVR Without Sentinel: deaths from any cause	Trial comparisons
TAVR With Sentinel vs TAVR Without Sentinel: The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)	Trial comparisons
TAVR With Sentinel vs TAVR Without Sentinel: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04149535

GET https://conductscience.org/api/trials/v1/NCT04149535/events?page=2

API reference For AI assistants