Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

Summary

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

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

Conditions2

Locations1 site

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