TCEP in VIV TAVR for Aortic Valve Disease

Overseen By Sheila Erwin, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Luke's Health System

Disqualifiers: Carotid stenosis, Cerebrovascular event, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: During surgical procedure

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the SENTINEL transcatheter cerebral embolic protection (TCEP) device to determine how much debris it can capture during a specific heart valve procedure. The focus is on patients with worn-out artificial aortic valves who require valve-in-valve transcatheter aortic valve replacement (VIV TAVR). This procedure is intended for those who face too much risk with open-heart surgery. Candidates typically have severe aortic valve issues and cannot undergo traditional surgery. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future heart procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the SENTINEL TCEP device is safe for use in VIV TAVR?

Research has shown that the SENTINEL device, used during certain heart procedures, is generally safe. One study found that the device successfully caught debris in 99% of patients, indicating it worked well without causing major issues. Another study confirmed it met safety standards by not increasing the risk of serious heart or brain problems within 30 days of use. Additionally, using the SENTINEL device was linked to fewer strokes without adding extra risk to patients. Overall, these findings suggest that the SENTINEL device is well-tolerated and does not cause significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SENTINEL transcatheter cerebral embolic protection (TCEP) device because it offers a new way to protect the brain during valve procedures for aortic valve disease. Unlike traditional approaches, this device specifically targets embolic debris that can travel to the brain during a transcatheter aortic valve replacement (TAVR), potentially reducing the risk of stroke. This targeted protection is a significant advancement, as current methods don't provide this focused level of cerebral protection. By incorporating this device, there is hope for safer outcomes and improved quality of life for patients undergoing this procedure.

What evidence suggests that the SENTINEL TCEP device is effective for aortic valve disease?

Research has shown that the SENTINEL device, which participants in this trial will receive, can lower the risk of stroke during heart valve replacement procedures. This device captures debris that could otherwise travel to the brain and cause damage. The SENTINEL is the only device of its kind approved by the FDA, proving its effectiveness in protecting the brain during these procedures. Specifically, the PROTECTED TAVR trial demonstrated that it effectively reduces stroke risk by catching tiny particles that can block blood vessels. Overall, the SENTINEL device adds an extra layer of safety during heart valve procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Adnan Chhatriwalla, MD

Principal Investigator

Saint Luke's Health System

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe degeneration of a previously placed artificial aortic valve who need a new non-surgical valve replacement. Candidates must have suitable blood vessel anatomy, be able to give informed consent, and commit to follow-up visits. They should not have had recent strokes, significant artery narrowing, certain heart conditions or be pregnant.

Inclusion Criteria

My heart valve replacement is failing and I need a procedure to fix it.

The patient is evaluated by the multidisciplinary heart-valve team and found to be suitable for the procedure

I can understand and am willing to sign the consent form.

Exclusion Criteria

You have a narrowed artery in the right side of your chest.

You have a blood clot in your left atrial appendage, as seen on certain imaging tests.

You are expected to live for less than one year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VIV TAVR with BVF using the SENTINEL TCEP device

During surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 days

Through hospital discharge

What Are the Treatments Tested in This Trial?

Interventions

• SENTINEL transcatheter cerebral embolic protection (TCEP) device

Trial Overview The study measures debris caught by the SENTINEL device during a special non-surgical procedure (VIV TAVR) that replaces failing artificial heart valves and uses balloon fracturing (BVF). The goal is to understand how much debris this protection device captures during the process.

How Is the Trial Designed?

Group I: VIV TAVR with BVF using TCEP Experimental Treatment 1 Intervention

All subjects will receive the intervention.

SENTINEL transcatheter cerebral embolic protection (TCEP) device is already approved in United States, European Union for the following indications:

Approved in United States as SENTINEL Cerebral Protection System for:

• Transcatheter aortic valve replacement (TAVR) procedures to capture and remove thrombus/debris

Approved in European Union as SENTINEL Cerebral Protection System for:

• Transcatheter aortic valve replacement (TAVR) procedures to capture and remove thrombus/debris

Who Is Running the Clinical Trial?

Saint Luke's Health System

Lead Sponsor

Trials

42

Recruited

12,600+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

Transcatheter cerebral embolic protection (TCEP) during transcatheter aortic valve replacement (TAVR) was found to be safe, with a major adverse cardiac and cerebrovascular event (MACCE) rate of 7.3%, which is significantly lower than the performance goal of 18.3%.

While TCEP captured embolic debris in 99% of patients, it did not lead to a statistically significant reduction in new brain lesion volume compared to the control group, indicating that while TCEP is safe, its efficacy in reducing brain lesions during TAVR needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. Kapadia, SR., Kodali, S., Makkar, R., et al.[2022]

The Sentinel cerebral embolic protection device (CEP) significantly reduces the risk of stroke during transcatheter aortic valve replacement (TAVR), with a risk ratio of 0.67, indicating a 33% lower risk compared to controls, and a number needed to treat (NNT) of 77.

Additionally, the use of the Sentinel CEP is associated with a lower risk of major or life-threatening bleeding (RR: 0.37), suggesting it may enhance safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral embolic protection during transcatheter aortic valve replacement: a systematic review and meta-analysis of propensity score matched and randomized controlled trials using the Sentinel cerebral embolic protection device. Wolfrum, M., Handerer, IJ., Moccetti, F., et al.[2023]

In a meta-analysis of four studies involving 1,330 patients, the use of the Sentinel Cerebral Protection System (CPS) during transcatheter aortic valve replacement (TAVR) significantly reduced the rates of 30-day mortality (0.8% vs 2.7%) and symptomatic stroke (3.5% vs 6.1%).

The Sentinel CPS also lowered the incidence of major or life-threatening bleeding (3.3% vs 6.6%), indicating its efficacy in enhancing patient safety during TAVR procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Sentinel Cerebral Protection System Use During Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Ndunda, PM., Vindhyal, MR., Muutu, TM., et al.[2021]

The Sentinel™ Cerebral Protection System (Sentinel-CPS) was successfully applied in 90.2% of the 92 patients undergoing TAVR, indicating its overall efficacy in preventing cerebral embolic events during the procedure.

Device failure was associated with higher tortuosity indices of the right subclavian and brachiocephalic arteries, as well as a brachiocephalic angle greater than 59°, suggesting that these anatomical features may complicate the deployment of the Sentinel-CPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical reasons for failure of dual-filter cerebral embolic protection application in TAVR: A CT-based analysis. Voss, S., Campanella, C., Burri, M., et al.[2022]

In a study of 411 patients undergoing transcatheter aortic valve replacement (TAVR), the use of the Sentinel™ Cerebral Protection System significantly reduced the rate of cerebrovascular events by 71% compared to those without the device.

Patients using Sentinel™ also experienced shorter hospital stays and improved 12-month survival rates, suggesting that this device not only helps prevent strokes but also enhances overall patient outcomes after TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral Protection in TAVR-Can We Do Without? A Real-World All-Comer Intention-to-Treat Study-Impact on Stroke Rate, Length of Hospital Stay, and Twelve-Month Mortality. Donà, C., Koschutnik, M., Nitsche, C., et al.[2022]

In a study of 20 patients undergoing transcatheter aortic valve replacement (TAVR), the use of the Sentinel Cerebral Protection System (Sentinel-CPS) did not lead to significant differences in cumulative cerebral desaturation compared to those without the device.

The insertion and manipulation of the Sentinel-CPS in the brain-supplying arteries did not negatively impact cerebral perfusion or oxygenation, indicating its safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a dual-filter-based cerebral embolic protection device in transcatheter aortic valve replacement on cerebral oxygen saturation: A prospective pilot study. Voss, S., Ernst, A., Erlebach, M., et al.[2021]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204961

Cerebral Embolic Protection during Transcatheter Aortic- ... The PROTECTED TAVR trial was conducted to investigate whether CEP reduces the risk of periprocedural stroke with TAVR.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093944/

Cerebral Embolic Protection in Transcatheter Aortic Valve ... The Sentinel™ cerebral protection system (CPS) is the only US Food and Drug Administration (FDA)-approved TCEP device. We performed a systematic ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.028890

Outcomes of Cerebral Embolic Protection for Bicuspid ... There is a significantly increasing cerebral embolic protection (CEP) use rate during transcatheter aortic valve replacement (TAVR) for bicuspid ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05093764?cntry=US

Quantification of Debris Captured Using TCEP During VIV ... The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients ...

5. jacc.org jacc.org/doi/10.1016/j.jcin.2025.06.019

Sentinel Cerebral Embolic Protection During Transcatheter ... The MISTRAL-C2 and SENTINEL (Cerebral Protection in Transcatheter Aortic Valve Replacement) trials reported subacute outcomes, while the other 3 reported acute ...

6. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/cerebral-protection-systems/sentinel-cerebral-protection-system/fp90000121.html

SENTINEL™ Cerebral Protection System The SENTINEL™ CPS captures and removes debris loosened during TAVR procedures. Learn how SENTINEL protects patients from embolic debris.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10276451/

Cerebral embolic protection during transcatheter aortic ... The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.