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
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
Treatments tested in this trial
- VIV TAVR with BVF using TCEP
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Saint Luke's Health System
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov