Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Saint Luke's Health System
Study ID
NCT05093764
Status
Recruiting
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Conditions

  • Aortic Valve Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VIV TAVR with BVF using TCEP — DEVICE
    The insertion and retrieval of the SENTINEL device is performed at the time of the patients TAVR procedure in the same setting while they are sedated under moderate sedation or general anesthesia depending on the case. The device is inserted at the initiation of the procedure through 6F right radial artery access and the filters are positioned in the left common carotid artery and brachiocephalic artery. After deployment, the usual TAVR procedure is performed. At the conclusion of the procedure, the SENTINEL device is extracted and hemostasis is achieved at the radial access site in the usual fashion with patent hemostasis.

Study Details

The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF)

Key Dates

Start date
Mar 2, 2022
Status verified
Jun 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: VIV TAVR with BVF using TCEP
    All subjects will receive the intervention.

Primary Outcome Measure

Quantity of debris [ Time Frame: During surgical procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111
Sheila Erwin, RN
[email protected]
816-932-7996
Adnan Chhatriwalla, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Saint Luke's Hospital of Kansas City· Kansas City, MO

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