Embolic Protection Device for Heart Valve Surgery

(EMPRO Trial)

Recruiting at 31 trial locations

Overseen By Claudia Merlin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Stroke, Endocarditis, Cardiogenic shock, others

Compensation: Varies

Number of Visits: 91

842 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the CardioGard Embolic Protection Cannula to determine its effectiveness in protecting the brain during high-risk heart valve surgeries. The trial compares the CardioGard Cannula with a standard aortic cannula to assess which performs better during surgery. It targets individuals aged 60 and older who plan to undergo specific heart valve surgeries and have no recent stroke history or neurological issues. Participants must understand and agree to the trial requirements. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance surgical outcomes for future patients.

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. Please consult with the trial coordinators for guidance.

What prior data suggests that the CardioGard Embolic Protection Cannula is safe for heart valve surgery?

Research shows that the CardioGard Embolic Protection Cannula is safe for use in heart surgery. Studies have demonstrated that it effectively captures debris during surgery, reducing the risk of stroke. The device protects the brain by catching tiny particles that might otherwise travel there.

In previous studies, the CardioGard cannula was used safely and effectively in open-heart surgeries. It successfully removed a large amount of debris, proving its effectiveness. These studies reported no serious safety issues or negative effects, indicating the device is well-tolerated.

While the current trial phase does not focus on safety, existing evidence suggests that the CardioGard cannula is a promising and safe option for patients undergoing high-risk valve surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CardioGard Embolic Protection Cannula because it offers a new way to protect the brain during heart valve surgery. Unlike standard aortic cannulas, which are commonly used in these procedures, the CardioGard device is designed to capture and remove embolic debris, potentially reducing the risk of stroke and other complications. This innovative approach focuses on enhancing patient safety by preventing harmful particles from reaching the brain, which is a significant advancement over traditional techniques that do not offer this type of protection.

What evidence suggests that the CardioGard Embolic Protection Cannula is effective for heart valve surgery?

In this trial, participants will join one of two groups. Research has shown that the CardioGard Embolic Protection Cannula, used by one group, performs well during heart valve surgeries. It helps remove small blockages, known as emboli, which can cause complications. This device reduces the risk of blockages during surgery, crucial for high-risk patients. Studies have demonstrated its safety and effectiveness, suggesting it might offer better protection than the Standard Aortic Cannula used by the other group. ^{1 2 3 4 5}

Who Is on the Research Team?

Annetine C. Gelijns, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Steve Messe, MD

Principal Investigator

University of Pennsylvania

Alexander Iribarne, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older who need certain heart valve surgeries, possibly with bypass grafting. They must be able to consent and follow the study plan, have no recent strokes or neurological issues, and not require long-term ventilation post-surgery. Those with active infections in the heart, recent heart procedures, or participation in other drug/device trials are excluded.

Inclusion Criteria

I am 60 years old or older.

I am scheduled for a heart valve surgery, which may include bypass grafting.

I have no significant neurological issues as per recent tests.

Exclusion Criteria

Participation in an interventional (drug or device) trial

I have had surgery to repair my mitral and/or tricuspid valve.

I have not had a stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Surgery

Patients are randomized to either the CardioGard Embolic Protection Cannula or a standard aortic cannula and undergo valve surgery

1 day

1 visit (in-person, surgical procedure)

Post-Surgery Monitoring

Patients are monitored for ischemic stroke, acute kidney injury, and other outcomes within 7 days post-randomization

7 days

Daily monitoring during hospital stay

Follow-up

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

12 months

Regular follow-up visits, including assessments at 90 days and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CardioGard Embolic Protection Cannula
• Standard Aortic Cannula

Trial Overview The trial is testing a new device called CardioGard Embolic Protection Cannula against the standard cannula used during high-risk valve surgeries. It's designed to see if CardioGard can better protect patients from debris that might cause complications like stroke during surgery.

How Is the Trial Designed?

Group I: CardioGard Embolic Protection Cannula Active Control 1 Intervention

In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).

Group II: Standard Aortic Cannula Placebo Group 1 Intervention

In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice

CardioGard Embolic Protection Cannula is already approved in United States for the following indications:

Approved in United States as CardioGard Cannula for:

• High-risk valve surgery

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

The case series highlights the use of the TriGuard 3 Cerebral Embolic Protection Device during percutaneous left atrial appendage closure and ventricular tachycardia catheter ablation in patients with intracardiac thrombosis, suggesting a potential for improved safety in these high-risk procedures.

Embolic cerebral protection devices like TriGuard 3 are not commonly used in clinical practice, indicating a need for further investigation into their efficacy and routine application during electrophysiological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TriGuard Embolic Protection Device in percutaneous cardiac interventions with intracavitary cardiac thrombosis: A case series. Marcon, L., Sicuso, R., Galli, S., et al.[2023]

In a study involving 797 patients undergoing percutaneous coronary intervention (PCI) for saphenous vein grafts, the Interceptor PLUS Coronary Filter System demonstrated noninferior safety and efficacy compared to established embolic-protection devices, with similar rates of major adverse cardiovascular events (8% for Interceptor vs. 7.3% for controls).

The trial confirmed that both the Interceptor PLUS and control devices had comparable success rates in preventing complications like death, myocardial infarction, or urgent repeat revascularization within 30 days, indicating that the new device is a viable alternative to existing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel filter-based distal embolic protection device for percutaneous intervention of saphenous vein graft lesions: results of the AMEthyst randomized controlled trial. Kereiakes, DJ., Turco, MA., Breall, J., et al.[2014]

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]

The off-label use of a dual-filter cerebral embolic protection device (CEPD) during thoracic endovascular aortic repair (TEVAR) in two high-risk patients successfully captured embolic debris, suggesting its potential for stroke prevention in this procedure.

Both patients experienced no neurological deficits or complications related to the device, indicating that the dual-filter CEPD can be safely used in TEVAR without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Dual-Filter Cerebral Embolic Protection Device in Thoracic Endovascular Aortic Repair. Shah, AS., Akhmerov, A., Gupta, N., et al.[2020]

The new Dispersion aortic cannula technique for perfusion toward the aortic valve was assessed in 100 patients and showed no complications related to its use, indicating it is a safe alternative for patients with severe atherosclerosis in the aortic arch.

This technique allowed for effective cross-clamping of the ascending aorta without perfusion issues, and while there were two neurologic events post-surgery, they were not related to the cannulation, suggesting the method is hemodynamically effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of perfusion toward the aortic valve using the new dispersion aortic cannula during coronary artery bypass surgery. Grooters, RK., Thieman, KC., Schneider, RF., et al.[2018]

The Dispersion cannula significantly reduces perfusion velocity compared to both the standard steel-tip and Soft-Flow cannulas, which may help minimize the risk of atheroemboli during coronary artery surgery using cardiopulmonary bypass.

While all cannulas showed similar perfusion hemodynamics, the Dispersion cannula's unique broad wedge-shaped perfusion pattern could potentially enhance patient safety by reducing the likelihood of dislodging aortic arch atheroma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic comparison of the standard end-hole cannula, the soft-flow cannula, and the dispersion cannula during perfusion into the aortic arch. Grooters, RK., Ver Steeg, DA., Stewart, MJ., et al.[2019]

The innovative Embol-X cannula, designed with an intra-aortic filter to capture atheromatous emboli, showed significantly higher pressure gradients and back pressures compared to traditional cannulae, indicating its potential effectiveness in preventing plaque dislodgement during cardiac surgery.

At a flow rate of 5.5 l/min, the Embol-X cannula demonstrated 48% and 62% higher pressure gradients than the Argyle and RMI cannulae, respectively, suggesting that its design may improve neurologic outcomes, warranting further in vivo studies to explore its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro hydrodynamics of the Embol-X cannula. Gerdes, A., Hanke, T., Sievers, HH.[2019]

The AV (Andrea Venturini) cannula offers a new technique for antegrade selective cerebral perfusion during aortic arch surgery, allowing for easier access to the supra-aortic vessels before hypothermic circulatory arrest.

This method enables the cannula to be placed without obstructing the ostia of the supra-aortic vessels, potentially speeding up surgical procedures like anastomosis or reimplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performing Antegrade Selective Cerebral Perfusion Using the AV Cannula: A Novel Approach. Venturini, A., Gallingani, A., Asta, A., et al.[2020]

In a study involving 7 domestic pigs, the novel CardioGard aortic cannula successfully retrieved 77% of emboli during cardiac surgery, with an impressive 88.45% retrieval rate during low-flow conditions, indicating its efficacy in preventing stroke-related complications.

The CardioGard cannula demonstrated a safety profile comparable to standard aortic cannulas, with no significant changes in hemodynamic or laboratory parameters, suggesting it can be safely integrated into surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel emboli protection cannula during cardiac surgery: first animal study. Shani, L., Cohen, O., Beckerman, Z., et al.[2016]

The newly designed Soft Flow arterial cannula significantly reduces exit force and flow velocity compared to five commonly used cannulae, which may help minimize the risk of atheroembolism during open heart surgery.

Despite the reduced exit force and velocity, the Soft Flow cannula maintains similar hemolysis rates as other cannulae, indicating it is a safe option without increasing the risk of blood cell damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flow characteristics of aortic cannulae. Muehrcke, DD., Cornhill, JF., Thomas, JD., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06027788

Study Details | NCT06027788 | CTSN Embolic Protection ... This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25258158/

Novel emboli protection system during cardiac surgery The CardioGard cannula is safe and efficient in use during open-heart surgery. Efficacy was demonstrated by the removal of a substantial amount of emboli, ...

3. acc.org acc.org/latest-in-cardiology/clinical-trials/2017/03/18/07/18/cerebral-embolic-protection-devices-during-savr

Cerebral Embolic Protection Devices During SAVR The goal of the trial was to assess the safety and efficacy of two embolic protection devices, CardioGard and Embol-X, in reducing central ...

4. withpower.com withpower.com/trial/phase-ischemic-stroke-8-2023-7283d

Embolic Protection Device for Heart Valve Surgery This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients. Show more.

5. jtcvs.org jtcvs.org/article/S0022-5223(14)00007-5/fulltext

A novel emboli protection cannula during cardiac surgery The main finding of the current study is that the novel research aortic cannula enabled the retrieval of most of the embolic material released ...