Embolic Protection Device for Heart Valve Surgery

(EMPRO Trial)

Recruiting at 28 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

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery 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 data supports the effectiveness of the treatment CardioGard Embolic Protection Cannula for heart valve surgery?

Research on similar devices, like the Dispersion aortic cannula, shows that perfusion toward the aortic valve can be safe and effective, with no complications related to the cannula insertion or perfusion. Additionally, innovative cannula designs, such as the Embol-X, aim to capture emboli (blockages) during surgery, which is crucial for preventing strokes. ^{1 2 3 4 5}

Is the Embolic Protection Device for Heart Valve Surgery safe for humans?

Research on similar devices, like the Embol-X cannula, shows they are designed to reduce the risk of dislodging debris during heart procedures, which can help prevent complications like stroke. These devices aim to safely capture debris in the aorta, suggesting a focus on safety in their design. ^{4 5 6 7 8}

How is the CardioGard Embolic Protection Cannula treatment different from other treatments for heart valve surgery?

The CardioGard Embolic Protection Cannula is unique because it is designed to capture debris during heart valve surgery, potentially reducing the risk of stroke or neurological injury, which is a concern with other treatments that do not have this protective feature. ^{1 8 9 10 11}

Research Team

Alexander Iribarne, MD

Principal Investigator

Northwell Health

Annetine C. Gelijns, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Steve Messe, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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]

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]

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]

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 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]

References

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

Assessment of perfusion toward the aortic valve using the new dispersion aortic cannula during coronary artery bypass surgery. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Performing Antegrade Selective Cerebral Perfusion Using the AV Cannula: A Novel Approach. [2020]

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

Novel emboli protection cannula during cardiac surgery: first animal study. [2016]

4. England pubmed.ncbi.nlm.nih.gov

In vitro hydrodynamics of the Embol-X cannula. [2019]

5. Netherlands 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. [2019]

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

Flow characteristics of aortic cannulae. [2019]

7. United States 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. [2014]

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

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

9. 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]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Use of a Dual-Filter Cerebral Embolic Protection Device in Thoracic Endovascular Aortic Repair. [2020]

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

TriGuard Embolic Protection Device in percutaneous cardiac interventions with intracavitary cardiac thrombosis: A case series. [2023]