Actively Recruiting
Quantification of Debris Captured Using TCEP During VIV TAVR With BVF
Led by Saint Luke's Health System · Updated on 2024-06-14
20
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
S
Saint Luke's Health System
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Quantification of Debris Captured Using TCEP During VIV TAVR With BVF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Severe bioprosthetic aortic valve degeneration with clinical indication for valve in valve transcatheter aortic valve replacement
- Bioprosthetic valve can be fractured with high pressure balloon inflation
- High or prohibitive mortality risk for surgical aortic valve replacement as assessed by the Heart Team
- CT angiogram of chest, abdomen, and pelvis confirming adequate femoral access and appropriate right subclavian, carotid, brachiocephalic, and left carotid artery anatomy
- Able and willing to provide written informed consent
- Able and willing to return for follow-up visits and examinations
- Evaluated by a multidisciplinary heart-valve team and found suitable for the procedure
You will not qualify if you...
- Low or moderate mortality risk from surgical aortic valve replacement
- Bioprosthetic valves that cannot be fractured with standard non-compliant valvuloplasty balloons
- Significant carotid artery stenosis (50% or more) on ultrasound or CT angiography
- Right subclavian or brachiocephalic artery stenosis
- Presence of right arm or forearm dialysis fistula or graft
- Harvested right radial artery from previous coronary bypass surgery
- Prohibitive aortic arch anomalies preventing SENTINEL device implantation
- History of cerebrovascular event within 6 months
- Incidental left atrial appendage thrombus on imaging
- Active enrollment in another cardiovascular device or investigational drug trial
- Pregnancy or planned pregnancy during the study if of child-bearing potential
- Any clinically significant medical condition or lab abnormality interfering with study or procedure guidelines
- Life expectancy less than one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
Research Team
S
Sheila Erwin, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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