Not Yet RecruitingNot Applicable

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

663 participantsStarted 2026-02

Plain-language summary

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.

Who can participate

Age range22 Years

SexALL

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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
✓. 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:

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

What they're measuring

Non-Inferiority

Timeframe: Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate

Trial details

NCT IDNCT07276711

SponsorEmStop Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Katherine Vo

763-227-9954 k.vo@emstopeps.com

View on ClinicalTrials.gov More Aortic Valve Stenosis trials