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Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

ConditionAortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Luke's Health System

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and Women ≥ 18 years of age

The patient has severe bioprosthetic aortic valve degeneration (stenosis, insufficiency, or mixed valve disease) and a clinical indication for VIV TAVR

The bioprosthetic valve can be fractured with high pressure balloon inflation.

The patient is deemed at prohibitive or high mortality risk related to surgical aortic valve replacement as assessed by the Heart Team

Disqualifiers

Patients with low or moderate mortality risk from surgical aortic valve replacement

Patients with bioprosthetic valves that cannot be fractured with standard non-compliant valvuloplasty balloons (Table 1)

Patients with evidence of significant carotid artery stenosis (i.e., carotid stenosis ≥ 50%), noted on ultrasound duplex imaging or CT angiography.

Patients with evidence of right subclavian/brachiocephalic artery stenosis

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: VIV TAVR with BVF using TCEPOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Complication rate

In-hospital stroke, device embolization rate, procedure-related major bleeding

Time frame
Through hospital discharge, an average of 2.5 days

Secondary outcomes

1

Mortality

Deaths from all causes

Time frame
Through hospital discharge, an average of 2.5 days
2

MACCE

Major adverse cardiac and cerebrovascular events

Time frame
Through hospital discharge, an average of 2.5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint Luke's Health System

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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