Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Quantification of Debris Captured Using Transcatheter Cerebral Embolic Protection (TCEP) During Valve in Valve Transcatheter Aortic Valve Replacement (VIV TAVR) With Bioprosthetic Valvular Fracture (BVF)

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: VIV TAVR with BVF using TCEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 For procedural planning, all patients must have a CT angiogram of the chest, abdomen and pelvis to confirm: 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. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial The patient is able and willing to return for required follow-up visits and examinations The patient is evaluated by the multidisciplinary heart-valve team and found to be a suitable for the procedure. Exclusion Criteria: 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 Patients with right arm/forearm dialysis fistula or graft. Patients with harvested right radial artery for a previous coronary bypass surgery. Patients with prohibitive aortic arch anomalies for SENTINEL device implantation. The patient with history of cerebrovascular event (CVA) within within 6 months. Patient with incidental left atrial appendage thrombus noted on TEE or CT imaging. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable) The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child-bearing potential Any clinically significant medical condition or presence of any laboratory abnormality performed prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or SENTINEL The patient has a life expectancy of less than one year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VIV TAVR with BVF using TCEP<br>All subjects will receive the intervention. | Device: VIV TAVR with BVF using TCEP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of debris | Amount of debris captured by the SENTINEL TCEP device in VIV TAVR with BVF patients compared to historical data | During surgical procedure | 
| Complication rate | In-hospital stroke, device embolization rate, procedure-related major bleeding | Through hospital discharge, an average of 2.5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Deaths from all causes | Through hospital discharge, an average of 2.5 days | 
| MACCE | Major adverse cardiac and cerebrovascular events | Through hospital discharge, an average of 2.5 days |