ProtEmbo vs Sentinel for Aortic Stenosis

Recruiting at 23 trial locations

Overseen By Karl von Mangoldt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Protembis GmbH

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Renal insufficiency, COPD, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special device called the ProtEmbo, designed to protect the brain during a heart valve procedure known as TAVR. Researchers aim to compare the effectiveness of this device against another device, the Sentinel, and the absence of any device. The trial targets individuals with severe symptoms from a narrowed heart valve who are scheduled for TAVR. Candidates may qualify if their doctor has recommended TAVR due to their heart condition. As an unphased trial, this study provides a unique opportunity to contribute to advancements in heart valve procedures.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a contraindication for anticoagulant or antiplatelet therapy, you may not be eligible to participate.

What prior data suggests that the ProtEmbo Cerebral Embolic Protection device is safe for use during TAVR procedures?

Research has shown that the ProtEmbo Cerebral Embolic Protection device is generally well-tolerated by patients undergoing transcatheter aortic valve replacement (TAVR). In the PROTEMBO C Trial, researchers assessed the device's safety and effectiveness for these patients. The results indicated that the device was safe, with no major issues reported during the trial.

The PROTEMBO SF Trial also evaluated the safety of the ProtEmbo device and found it practical to use, functioning well without major problems. Although the studies do not provide exact numbers of side effects, the fact that these devices are being tested in clinical trials suggests they have demonstrated sufficient safety promise for further investigation.

In summary, the available data suggest that the ProtEmbo device is relatively safe, with no major side effects reported in previous studies. However, like any medical treatment, it may still carry some risks, and discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PROTEMBO trial because it explores new ways to protect the brain during Transcatheter Aortic Valve Replacement (TAVR) by using cerebral embolic protection devices. Unlike the standard care, which often includes devices like the Sentinel, the ProtEmbo device aims to offer a novel approach to safeguard against embolic debris reaching the brain during the procedure. This could potentially reduce the risk of stroke, a known complication of TAVR. By comparing ProtEmbo directly with Sentinel and a control group with no embolic protection, the trial hopes to reveal if there’s a superior method for enhancing patient safety during TAVR.

What evidence suggests that the ProtEmbo and Sentinel devices are effective for cerebral embolic protection during TAVR?

In this trial, participants will join different arms to evaluate the effectiveness of cerebral embolic protection devices during transcatheter aortic valve replacement (TAVR). Research shows that devices like ProtEmbo, used in one arm of this trial, catch debris during procedures such as TAVR, helping to prevent strokes by stopping tiny particles from reaching the brain. Previous studies found that using the ProtEmbo device is safe and feasible. Another arm of this trial will use the Sentinel device, also designed for cerebral embolic protection. However, strong evidence is lacking that these devices effectively reduce strokes or the size of brain lesions. Some studies suggest these devices might lower certain risks during TAVR, but clear benefits for all patients remain unproven. Participants in the control arm will undergo TAVR without embolic protection. ^{1 4 6 7 8}

Who Is on the Research Team?

Roxana Mehran, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

The heart team recommends transcatheter aortic valve replacement via femoral access consistent with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

The subject and the treating physician agree that the subject will undergo the scheduled pre procedural testing and return for all required post procedure follow up visits.

The subject is able to provide informed consent, has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the relevant regulatory authority of the respective clinical site.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TAVR with or without cerebral embolic protection devices

1 day

1 visit (in-person)

Immediate Post-Treatment Assessment

Participants undergo MRI to evaluate new cerebral lesions

36 ±12 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including MACCE assessment

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ProtEmbo
• Sentinel

How Is the Trial Designed?

Group I: ProtEmbo - Cerebral Embolic Protection Experimental Treatment 1 Intervention

Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.

Group II: Sentinel - Cerebral Embolic Protection Active Control 1 Intervention

Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.

Group III: Control Arm Active Control 1 Intervention

Subjects will undergo TAVR without embolic protection.

Who Is Running the Clinical Trial?

Protembis GmbH

Lead Sponsor

Trials

3

Recruited

570+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10241272/

the PROTEMBO C Trial - PMC - PubMed Central Recent randomised clinical trials evaluating CEPDs have demonstrated safety without convincing evidence of benefit in reducing stroke or total lesion volume on ...

2. eurointervention.pcronline.com eurointervention.pcronline.com/article/final-report-of-the-protembo-c-trial-a-prospective-evaluation-of-a-novel-cerebral-protection-device-during-tavi

Final report of the PROTEMBO C Trial: a prospective ... PROTEMBO C Trial evaluated a novel cerebral protection device, the ProtEmbo filter, in 50 patients undergoing TAVI. It was found to be safe and feasible ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04618718

Study Details | NCT04618718 | The PROTEMBO C Trial The heart team recommends transcatheter valve aortic valve replace consistent with the 2017 ESC/EACTS Guidelines for the management of valvular heart disease.

4. mdpi.com mdpi.com/2077-0383/13/23/7256?

2024 Update on Cerebral Embolic Protection After ... The use of cerebral embolic protection devices during transcatheter aortic valve replacement has shown promise in capturing embolic debris and reducing certain ...

5. uscjournal.com uscjournal.com/articles/cerebral-embolic-protection-devices-current-state-art?language_content_entity=en

Cerebral Embolic Protection Devices: Current State of the Art Efficacy and safety of cerebral embolic protection systems during transcatheter aortic valve replacement: a review of current clinical findings.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03325283?cond=protembo&rank=3

Study Details | NCT03325283 | The PROTEMBO SF Trial The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030587

Role of Cerebral Embolic Protection Devices in Patients ... The use of CEPD in transcatheter aortic valve replacement was not associated with a statistically significant reduction in the risk of clinical, neurological, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35608032/

the PROTEMBO C Trial The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients.