Rapid City, SDNCT07276711Now EnrollingIRB Ready

Aortic Valve Stenosis Clinical Trial in Rapid City, SD

Access cutting-edge aortic valve stenosis treatment through this clinical trial at a research site in Rapid City. Study-provided care at no cost to qualified participants.

Sponsored by EmStop Inc

Quick Self-Assessment

See if you qualify for this Rapid City location

Preparing your pre-screening questions…

Expert Care in Rapid City

Access aortic valve stenosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic valve stenosis treatment provided free

Apply for This Rapid City Location

Check if you qualify for this aortic valve stenosis clinical trial in Rapid City, SD

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Rapid City

    Convenient for SD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rapid City site if eligible
  4. 4Begin participation

About This Aortic Valve Stenosis Study in Rapid City

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.

Sponsor: EmStop Inc

Who Can Participate

Inclusion Criteria

Age ≥ 22 years at the time of consent
Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.
Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram
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 Imaging Inclusion Criteria
Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.
Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria: EmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:
Ascending aorta length ≥8 cm
Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm
Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm.
Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification Sentinel Angiographic (CTA) Inclusion Criteria 1\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:
Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery
Arterial stenosis \<70% in either the left common carotid artery or the brachiocephalic artery
Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
Adequate blood flow to the right upper extremity
Access vessels without excessive tortuosity

Exclusion Criteria

Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \[NIHSS\] \>1 at baseline)
Left ventricular ejection fraction \<30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure
Acute myocardial infarction (MI) within 30 days of the planned index procedure
Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.
Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min
Hypercoagulable state that cannot be corrected by additional periprocedural heparin
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
Undergoing therapeutic thrombolysis
History of bleeding diathesis or major coagulopathy
Hepatic failure (Child-Pugh class C)
Active endocarditis or ongoing systemic infection, defined as fever (\>38°C) and/or WBC \>15,000 IU
Known allergy to any materials used in the EmStop system (e.g., nitinol)
Currently participating in another drug or device clinical study
Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure
Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rapid City?

Yes, this clinical trial (NCT07276711) has an active research site in Rapid City, SD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Aortic Valve Stenosis Treatment Options in Rapid City, SD

If you're searching for aortic valve stenosis treatment options in Rapid City, SD, this clinical trial (NCT07276711) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rapid City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic valve stenosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all aortic valve stenosis clinical trials near you to find additional studies recruiting in your area.

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