Aortic Valve StenosisCAPTURE-1NCT06103591
Controlled Arterial Protection to Ultimately Remove Embolic Material
A study testing The EmStop Embolic Protection System (EmStop System) in people with Aortic Valve Stenosis, run by EmStop Inc at 2 sites in United States.
Trial summary
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- The EmStop Embolic Protection System (EmStop System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2023to 14 Oct 2024
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical \& Angiographic Inclusion Criteria
- Between 21 and 90 years of age at the time of consent
- Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve
- Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
- Willing and able to comply with the protocol-specified procedures and assessments
- Subject anatomy is compatible with correct device deployment and positioning with:
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- Ability to achieve access with a 21 French equivalent femoral access sheath
- Ascending aorta length ≥8 cm
- Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm
- Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification
Who cannot join
- Requires urgent or emergent TAVR procedure
- Contraindicated to MRI
- Previously implanted aortic or mitral valve bioprosthesis
- Hepatic failure (Child-Pugh class C)
- Hypercoagulable state that cannot be corrected by additional periprocedural heparin
- Planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted up until baseline MRI is obtained. Once baseline MRI is obtained, no additional intra-aortic or intracardiac procedure may occur.
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- Acute myocardial infarction within 30 days of the planned index procedure
- Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
- Documented history of stroke or TIA within the prior 6 months, or any prior stroke with a permanent major disability or deficit (NIHSS >1 at baseline)
- Left ventricular ejection fraction ≤30% within 3 months prior to procedure
- History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated
- Known allergy or sensitivity to nickel-titanium
- Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or white blood cell (WBC) >15,000 IU
- Undergoing therapeutic thrombolysis
- History of bleeding diathesis or a coagulopathy
- Known or suspected to be pregnant, or is lactating; female subjects of child-bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
- Currently participating in another drug or device clinical study
- Any other clinical reason, as deemed by the investigators of the study, by which the patient would not be an appropriate candidate for the study
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mission Health
Asheville, North Carolina, 28801
Centennial Medical Center
Nashville, Tennessee, 37203
About this study
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
Read the detailed description
The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.
- Conditions
- Aortic Valve Stenosis
- Being tested
- The EmStop Embolic Protection System (EmStop System)
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EmStop Embolic Protection System (EmStop System)Device
The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
| Study group | Role | What they receive |
|---|---|---|
| EmStop Embolic Protection System | Experimental | Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). Receives: Device: The EmStop Embolic Protection System (EmStop System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedural Success
Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference
Measured: During the procedure
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)
Measured: 30 days follow-up
Secondary outcomes (4)
Average Number of Captured Embolic Debris
Device filters were shipped to an independent pathology core laboratory where debris were counted and assessed
Measured: During the procedure
Average Number of Captured Particles ≥140 μm in Diameter
Assessed by an independent pathology core laboratory
Measured: Procedural
Total Acute Infarct Burden
As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. A baseline DW-MRI was collected and evaluated in comparison to the post-procedure DW-MRI.
Measured: 14 days pre-procedure to 18-36 hours post-procedure
Occurrence of Transient Ischemic Attack (TIA)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start27 Dec 2023
- Primary completion4 Sep 2024
- Study completion14 Oct 2024
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.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmStop Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Emily Vollbrecht, Study director, Bright Research Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103591
- Sponsor's protocol ID
- EMS-CL-5000
- Acronym
- CAPTURE-1
- Status last verified
- Apr 2025
- First submitted
- 19 Oct 2023
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Arterial Protection to Ultimately Remove Embolic Material
- ClinicalTrials.gov ID
- NCT06103591
- Acronym / sponsor ID
- CAPTURE-1 / EMS-CL-5000
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EmStop IncIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
Detailed description
The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EmStop Embolic Protection System | Experimental | Device: The EmStop Embolic Protection System (EmStop System)Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical \& Angiographic Inclusion Criteria
- Between 21 and 90 years of age at the time of consent
- Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve
- Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
- Willing and able to comply with the protocol-specified procedures and assessments
Key exclusion criteria (19 listed)
- Requires urgent or emergent TAVR procedure
- Contraindicated to MRI
- Previously implanted aortic or mitral valve bioprosthesis
- Hepatic failure (Child-Pugh class C)
- Hypercoagulable state that cannot be corrected by additional periprocedural heparin
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 |
|---|---|---|
| The EmStop Embolic Protection System (EmStop System)The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures. | Device | EmStop Embolic Protection System |
Primary outcome
Number of Participants With Procedural Success
Time frame: During the procedure
Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Time frame: 30 days follow-up
Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)
4 secondary outcomes
Average Number of Captured Embolic Debris
Time frame: During the procedure
Average Number of Captured Particles ≥140 μm in Diameter
Time frame: Procedural
Total Acute Infarct Burden
Time frame: 14 days pre-procedure to 18-36 hours post-procedure
Occurrence of Transient Ischemic Attack (TIA)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Emily Vollbrecht study director
Bright Research Partners
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The EmStop Embolic Protection System (EmStop System) in people with Aortic Valve Stenosis, run by EmStop Inc at 2 sites in United States.
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 10 inclusion and 19 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 29 Apr 2025). 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?
Number of Participants With Procedural Success (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.