Measuring debris during heart valve replacement procedures
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)
This study is testing if a special device can catch debris during heart valve replacement surgery in people who are at high risk for traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Luke's Health System Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT05093764 on ClinicalTrials.gov |
What this trial studies
This study aims to quantify the debris captured by the SENTINEL transcatheter cerebral embolic protection device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF). It is a prospective, single-center, single-arm pilot trial involving 20 subjects with severe symptomatic bioprosthetic aortic valve degeneration who are at high or prohibitive risk for surgical replacement. Participants will undergo an aortic arch angiogram, followed by the implantation of the SENTINEL device and the VIV TAVR procedure using a commercially available heart valve. The study will assess the effectiveness of the SENTINEL device in capturing debris during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe bioprosthetic aortic valve degeneration who are at high risk for surgical aortic valve replacement.
Not a fit: Patients with low-risk profiles for surgical aortic valve replacement or those without severe bioprosthetic aortic valve degeneration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety of VIV TAVR procedures by reducing the risk of cerebral embolic events.
How similar studies have performed: While this approach is novel in the context of VIV TAVR, similar studies using embolic protection devices have shown promise in other cardiac procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kansas City, Missouri
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Adnan Chhatriwalla, MD — Saint Luke's Health System
- Study coordinator: Sheila Erwin, RN
- Email: serwin@saintlukeskc.org
- Phone: 816-932-7996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.