Controlled Arterial Protection to Ultimately Remove Embolic Material
EmStop Inc
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.
Description
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Clinical Inclusion Criteria 1. Age ≥ 22 years at the time of consent 2. 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. 3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram 4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedur…
Interventions
- DeviceEmStop Embolic Protection System
EmStop Embolic Protection System used during TAVR procedure
- DeviceBoston Scientific Sentinel
Sentinel device used during TAVR procedure
Locations (2)
- Ochsner Medical CenterNew Orleans, Louisiana
- Mission HealthAsheville, North Carolina