An interventional study of EmStop Embolic Protection System and Boston Scientific Sentinel in Aortic Valve Stenosis, Aortic Stenosis and Aortic Valve Disease, sponsored by EmStop Inc. Recruiting at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by EmStop Inc · Not applicable, Interventional, and Treatment
Among 189 studies in Aortic Valve Stenosis with a site in United States — 44 open to participants now, 68 under way, 3 of them phase 3. Aortic Valve Stenosis · United States.
Among the 189 studies in Aortic Valve Stenosis with a site in United States, this one is the 32nd largest by planned enrollment of the 125 interventional ones that give a count, is one of 10 that started in 2026, is one of 102 with no phase, reaches primary completion later than 49 of the 67 other live ones, and was the 183rd registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 663 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →44 of the 189 studies in Aortic Valve Stenosis with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
The full table on the hub →189 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 7 · Phase 4 6
First in 2000; this study’s year is marked. 10 started in 2026.
Median enrollment 172 across the 125 interventional studies, 102 across the 64 observational. Of the 106 that completed or were terminated, 50 (47%) have results posted.
82 of 189 have an industry lead sponsor. The 10 most frequent:
EmStop Inc is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
EmStop Inc has 2 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
13 of the studies in Aortic Valve Stenosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06689839EnCompass Technologies, Inc.Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR | 2026-12 |
| NCT05603026University Hospitals Cleveland Medical CenterMRI in Transcatheter Aortic Valve Replacement Patients | 2026-12-30 |
| NCT07827105AccurKardia, Inc.ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting | 2027-02 |
| NCT06077201Vanderbilt University Medical CenterHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions | 2027-02-01 |
| NCT06580158Mayo ClinicAI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction | 2027-03 |
Among the 189 studies in Aortic Valve Stenosis with a site in United States, from their registry updates:
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.
This is a prospective, single-blind, multi-center, randomized study conducted in up to 25 U.S. investigational sites. Subjects with severe aortic valve stenosis (AS) will be randomized 2:1 to the EmStop Embolic Protection System (study device) versus the Sentinel device (control group) and followed to 30 days post TAVR procedure.
Clinical Inclusion Criteria
Imaging Inclusion Criteria
EmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:
Sentinel Angiographic (CTA) Inclusion Criteria
1. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: EmStop Embolic Protection System
Device: Boston Scientific Sentinel
EmStop Embolic Protection System used during TAVR procedure
Sentinel device used during TAVR procedure
Non-Inferiority
Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days
Time frame: Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate
Non-Inferiority
Hypothesis-driven secondary efficacy endpoint is the composite rate through 30-days post-procedure of NeuroARC defined ischemic embolic stroke, VARC-3 defined AKI, and systemic embolization
Time frame: 30 days
Debris Capture
Hypothesis-driven secondary efficacy endpoint is the total debris capture, defined as the number of captured particles of at least ≥ 150micron
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2028, 24 months after the start.
Of 111 industry-sponsored interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 24 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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