CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorEmStop Inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- EmStop Embolic Protection System
- Boston Scientific Sentinel
Treatment groups
663 Participants
are divided into 2 treatment groupsSponsors and collaborators
EmStop Inc
Lead sponsor
Bright Research Partners
Collaborator
Source ClinicalTrials.gov