EMBLOK EPS for Aortic Valve Disease

Overseen By Jeremy Moyer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Innovative Cardiovascular Solutions

Disqualifiers: Hepatic failure, Renal failure, Stroke, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

532 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems. This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that subjects with contraindications to anticoagulation and antiplatelet therapy are excluded, which might imply that certain medications could be relevant. Please consult with the trial coordinators for specific guidance.

Will I have to stop taking my current medications?

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

What data supports the idea that EMBLOK EPS for Aortic Valve Disease is an effective treatment?

The available research shows that using embolic protection devices (EPDs) like EMBLOK EPS during transcatheter aortic valve implantation (TAVI) can help reduce the risk of debris causing blockages in the brain, which can lead to strokes. Although some studies have mixed results, the general idea is that these devices can make the procedure safer by catching harmful particles. Compared to not using any protection, EPDs may lower the chance of brain-related complications during the procedure. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment EMBLOK™ Embolic Protection System for Aortic Valve Disease?

Research suggests that embolic protection devices, like the EMBLOK system, may help reduce the risk of stroke by capturing debris during procedures like aortic valve replacement. However, the evidence is mixed, and more studies are needed to confirm their effectiveness. ^{1 2 3 4 5}

What safety data exists for the EMBLOK EPS treatment for aortic valve disease?

The available research does not directly mention safety data for the EMBLOK EPS or its related names. However, studies on cerebral embolic protection devices (CEPDs) during transcatheter aortic valve implantation (TAVI) suggest that the safety and efficacy of such devices are still under evaluation, with mixed results from randomized clinical trials and observational studies. Specific safety data for EMBLOK EPS or SENTINEL CPS is not provided in the given research. ^{2 4 5 6 7}

Is the EMBLOK EPS safe for humans?

The safety of cerebral embolic protection devices, like the EMBLOK EPS, has been studied in procedures like transcatheter aortic valve implantation (TAVI). While the evidence is mixed, these devices are generally designed to prevent debris from causing harm during heart procedures, suggesting a focus on safety. ^{2 4 5 6 7}

Is the EMBLOK™ Embolic Protection System a promising treatment for aortic valve disease?

The EMBLOK™ Embolic Protection System is a promising treatment because it aims to protect the brain by capturing debris that can cause strokes during aortic valve procedures. This could potentially make the procedure safer for patients. ^{2 3 5 8 9}

How is the EMBLOK EPS treatment different from other treatments for aortic valve disease?

The EMBLOK EPS is unique because it is an embolic protection system designed to capture debris during procedures like aortic valve replacement, potentially reducing the risk of stroke or other complications. This is different from standard treatments that do not include such protective measures. ^{2 3 5 8 9}

Research Team

Hemal Gada, MD

Principal Investigator

Heart and Vascular Institute, UPMC Pinnacle

Eligibility Criteria

This trial is for adults aged 18-90 with aortic valve disease needing TAVR and can follow the study plan. Pregnant or breastfeeding women, those with recent heart attacks, urgent TAVR needs, allergies to device materials or contrast agents that can't be managed, severe liver/renal failure, bleeding disorders, history of stroke or major disability from it, ejection fraction ≤30%, and certain anatomical issues are excluded.

Inclusion Criteria

Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation

I am between 18 and 90 years old.

I am eligible for a TAVR procedure on my heart valve using an approved method.

Exclusion Criteria

My right arm's blood flow is not restricted, and it can support minor medical procedures.

The length of my ascending aorta is less than 7.5 cm.

You have had a bioprosthetic aortic or mitral valve implanted in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TAVR with either the EMBLOK EPS or SENTINEL CPS, including embolic protection and debris capture

1 week

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness, including detailed neurological assessments

4 weeks

1 visit (in-person) at 30 days

Long-term Follow-up

Participants may be monitored for long-term outcomes and safety

Up to 1 year

Treatment Details

Interventions

• EMBLOK™ Embolic Protection System
• SENTINEL™ Cerebral Protection System

Trial Overview The EMBLOK EPS is being tested against the SENTINEL Cerebral Protection System during TAVR procedures in patients with aortic valve disease. The goal is to compare safety and effectiveness through randomized assignment at multiple U.S. centers with follow-ups including neurological assessments.

Participant Groups

Group I: EMBLOK™ Embolic Protection System Experimental Treatment 1 Intervention

Device Description: The EMBLOK™ Embolic Protection System ("EMBLOK EPS") is a sterile, single use system designed to capture and remove debris (e.g., thrombus, calcium, atheroma) dislodged during transcatheter aortic valve replacement (TAVR) procedures. The device is currently for investigational use only. When Device Will Be Used: Roll-in: Prior to enrollment of the first randomized subject at each site, each site will enroll 2 Roll-In subjects, who will not be randomized but will receive the EMBLOK EPS during TAVR. Randomized: Up to 422 subjects meeting eligibility criteria will be randomized 1:1. The experimental "intervention" arm is utilizing EMBLOK EPS during TAVR (up to 211 subjects). Nested registry: Up to 50 subjects who meet clinical eligibility criteria and are anatomically suitable for the EMBLOK EPS, but whose anatomy precludes the use of the SENTINEL CPS.

Group II: SENTINEL™ Cerebral Protection System Active Control 1 Intervention

Device Description: The control comparator is the commercially-available SENTINEL™ Cerebral Protection System ("SENTINEL CPS") (Boston Scientific Corp., Marlborough, MA, US), a dual-filter protection device designed to capture and remove debris dislodged during TAVR procedures. The SENTINEL CPS is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing TAVR procedures. The diameters of the arteries at the site of filter placement should be between 9.0 mm - 15.0 mm for the brachiocephalic and 6.5 mm - 10.0 mm in the left common carotid. When Device Will Be Used: In the randomized cohort, up to 422 subjects meeting eligibility criteria will be randomized 1:1 (stratified by operative risk and study site). The active comparator "control" arm is utilizing SENTINEL CPS during TAVR (up to 211 subjects).

EMBLOK™ Embolic Protection System is already approved in United States for the following indications:

Approved in United States as EMBLOK EPS for:

• Transcatheter Aortic Valve Replacement (TAVR)

Who Is Running the Clinical Trial?

Innovative Cardiovascular Solutions

Lead Sponsor

Trials

2

Recruited

560+

Yale Cardiovascular Research Group

Collaborator

Trials

11

Recruited

4,000+

Findings from Research

The use of embolic protection devices (EPDs) during transcatheter aortic valve implantation (TAVI) is associated with a reduction in the total volume of cerebral lesions and improved neurocognitive outcomes, although it has not consistently shown a clinical prevention of embolic strokes across all studies.

In thoracic endovascular aortic repair (TEVAR), EPDs effectively capture embolic debris and prevent early postoperative neurocognitive deficits, while carbon dioxide flushing (CDF) has been shown to significantly reduce gaseous emboli during stent-graft deployment, indicating potential safety and efficacy, but further evidence is needed for routine clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for Cerebral Embolic Prevention in Transcatheter Aortic Valve Implantation and Thoracic Endovascular Aortic Repair. Lam, HT., Kwong, JM., Lam, PL., et al.[2019]

The EMBOL-X System device effectively captured particulate emboli during aortic valve replacement surgery in 38.5% of patients, indicating its potential to reduce embolic complications.

No major adverse events, such as strokes or renal failure, occurred in the 13 patients studied, suggesting that the use of the EMBOL-X System is safe during this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Particulate emboli capture by an intra-aortic filter device during aortic valve replacement. Leite Filho, OA., Brandão, CM., Pomerantzeff, PM., et al.[2019]

The use of embolic protection devices (EPD) during transcatheter aortic valve implantation is associated with a lower rate of 30-day strokes, with an odds ratio of 0.55, indicating a potential safety benefit.

While EPD did not significantly reduce mortality or the number of new ischemic lesions, it was linked to smaller volumes of ischemic lesions, suggesting it may help minimize the severity of brain damage during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis. Testa, L., Latib, A., Casenghi, M., et al.[2019]

The Embrella Embolic Deflector (EED) system was safely deployed in all 52 patients undergoing transcatheter aortic valve replacement (TAVR), with no complications reported during the procedure.

While the EED system did not prevent the occurrence of cerebral microemboli, it was associated with a significant reduction in the volume of new ischemic lesions compared to the control group, suggesting potential benefits in minimizing damage during TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and exploratory efficacy evaluation of the Embrella Embolic Deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study. Rodés-Cabau, J., Kahlert, P., Neumann, FJ., et al.[2022]

A meta-analysis of 10 studies involving 159,865 patients found that cerebral embolic protection devices (CEPDs) did not significantly reduce the risk of 30-day strokes during transcatheter aortic valve implantation (TAVI).

The analysis also showed no significant differences in silent ischemic lesions or neurocognitive function between patients who received CEPDs and those who did not, indicating that CEPDs may not provide the expected protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis. Pérez-Camargo, D., Travieso, A., Carnero-Alcázar, M., et al.[2022]

In a study involving 166 patients who received the Medtronic Advantage aortic valve prosthesis, the 30-day mortality rate was low at 2.4%, indicating a favorable safety profile shortly after surgery.

The valve demonstrated effective hemodynamic performance, with significant improvements in heart function, such as decreased left ventricular mass and increased fractional shortening, comparable to other bileaflet valves currently in use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study. Haaverstad, R., Vitale, N., Karevold, A., et al.[2019]

Transcatheter aortic valve implantation (TAVI) in failed bioprostheses is becoming more common, but it carries risks such as residual stenosis and potential coronary obstruction, which are significant concerns for patient safety.

Emerging techniques like bioprosthetic valve ring fracture and the BASILICA method (intentional laceration of aortic scallops) may help prevent these complications, highlighting the need for innovative approaches until more durable and safer prosthetic valves are developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel strategies in aortic valve-in-valve therapy including bioprosthetic valve fracture and BASILICA. Dvir, D., Khan, J., Kornowski, R., et al.[2019]

In a study of 30 high-risk patients undergoing transcatheter aortic valve implantation (TAVI), the use of the EMBOL-X protection device reduced the incidence of new cerebral lesions from 69% to 50% compared to those without the device.

Patients with the EMBOL-X device also experienced significantly smaller lesion volumes in the middle cerebral artery region, indicating that this device may enhance safety during TAVI procedures by minimizing the risk of stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation. Wendt, D., Kleinbongard, P., Knipp, S., et al.[2022]

Embolization of a transcatheter aortic valve, such as the Evolut R device, is a rare but serious complication that may require surgical intervention if it cannot be retrieved percutaneously.

The unique taller profile of the Evolut R device poses specific challenges for surgical retrieval, highlighting the importance of understanding device characteristics to ensure safe and effective surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Challenges in Retrieval of an Embolized Transcatheter Valve From the Aorta. Gopal, K., Madathil, T., Varma, PK.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence for Cerebral Embolic Prevention in Transcatheter Aortic Valve Implantation and Thoracic Endovascular Aortic Repair. [2019]

2. Brazil pubmed.ncbi.nlm.nih.gov

Particulate emboli capture by an intra-aortic filter device during aortic valve replacement. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Cerebral Protection During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta-Analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and exploratory efficacy evaluation of the Embrella Embolic Deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study. [2019]

7. France pubmed.ncbi.nlm.nih.gov

Novel strategies in aortic valve-in-valve therapy including bioprosthetic valve fracture and BASILICA. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Surgical Challenges in Retrieval of an Embolized Transcatheter Valve From the Aorta. [2021]