An interventional study of VIV TAVR with BVF using TCEP in Aortic Valve Disease, sponsored by Saint Luke's Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Saint Luke's Health System · Not applicable, Interventional, and Treatment
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)
SENTINEL VIV-TAVR is a prospective, single-center, single-arm, unblinded pilot trial. A total of 20 subjects with severe symptomatic bioprosthetic aortic valve degeneration, who are deemed to be at high or prohibitive mortality risk related to surgical aortic valve replacement, and are undergoing VIV-TAVR and BVF, will be enrolled at the Mid-America Heart Institute, St-Luke's Hospital of Kansas City. Subjects will initially have an aortic arch angiogram done to confirm appropriate anatomy, followed by the SENTINEL device implanted through right radial artery approach. After that, patients will undergo VIV TAVR, using a commercially available transcatheter heart valve, followed by bioprosthetic valve fracture (BVF) as indicated.
231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.
This study's planned enrollment of 20 is below the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Saint Luke's Health System is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A. Adequate femoral access for the TAVR procedure B. Appropriate right subclavian, carotid and brachiocephalic as well as left carotid artery anatomy for the SENTINEL device deployment.
Exclusion Criteria:
All subjects will receive the intervention.
Device: VIV TAVR with BVF using TCEP
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.
Quantity of debris
Amount of debris captured by the SENTINEL TCEP device in VIV TAVR with BVF patients compared to historical data
Time frame: During surgical procedure
Complication rate
In-hospital stroke, device embolization rate, procedure-related major bleeding
Time frame: Through hospital discharge, an average of 2.5 days
Mortality
Deaths from all causes
Time frame: Through hospital discharge, an average of 2.5 days
MACCE
Major adverse cardiac and cerebrovascular events
Time frame: Through hospital discharge, an average of 2.5 days
Plan to share: No
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