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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.
Full 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.
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Inclusion criteria
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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Central trial contact
Emily Vollbrecht; Scott Thome
Data sourced from clinicaltrials.gov
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