Embolic Protection Device for Heart Valve Surgery
(EMPRO Trial)
Recruiting in Palo Alto (17 mi)
+28 other locations
Overseen byAnnetine C. Gelijns, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Disqualifiers: Stroke, Endocarditis, Cardiogenic shock, others
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.
12345Is 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.
45678How 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.
1891011Eligibility 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.
+4 more
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.
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: CardioGard Embolic Protection CannulaActive Control1 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 CannulaPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell HealthNew York, NY
NYU Langone Hospital BrooklynNew York, NY
Duke UniversityDurham, NC
Emory UniversityAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Assessment of perfusion toward the aortic valve using the new dispersion aortic cannula during coronary artery bypass surgery. [2018]When there is an echocardiographic diagnosis of severe mobile atherosclerotic plaque in the aortic arch or descending aorta, perfusion toward the aortic arch during cardiopulmonary bypass may create a high risk of embolic neurologic injury. Other perfusion methods, such as cannulation of the femoral or axillary arteries, are not always possible, due to atherosclerosis. The ascending aorta may be an alternative site for perfusion, since it is less frequently diseased. We assessed a new technique of perfusion toward the aortic valve using a new cannula designed for this purpose (Dispersion aortic cannula). Our study included 100 consecutive patients, 72 men and 28 women, with an average age of 68 +/- 1.0 years (range, 39-89 years). There were no complications related to insertion of the cannula or perfusion. The ascending aorta could be cross-clamped and side-clamped without perfusion problems. Three deaths occurred; none was related to the cannulation technique. No intra-operative stroke occurred. Two patients suffered neurologic events, one on day 1 and the other on day 6; both had been fully alert after surgery. Perfusion toward the aortic valve appears to be safe and hemodynamically effective. This cannulation technique appears to be an acceptable alternative to present methods. Comparative studies will be needed to determine whether this alternative technique is effective in patients with severe aortic arch disease.
Performing Antegrade Selective Cerebral Perfusion Using the AV Cannula: A Novel Approach. [2020]Antegrade selective cerebral perfusion has become the preferred choice for brain protection during aortic arch surgery. To perform antegrade selective cerebral perfusion, cannulas have been introduced directly into the ostia of the supra-aortic vessels (SAV) after institution of hypothermic circulatory arrest and opening the aortic arch. We describe a different surgical technique with a new type of cannula for antegrade selective cerebral perfusion. This cannula, called AV (Andrea Venturini) cannula, has been designed to be introduced in the SAV directly using a standard guidewire technique (Seldinger's technique). The AV cannula can also be introduced from the ostia of the SAV if preferred. The AV cannula can be introduced before the institution of hypothermic circulatory arrest and before opening the aortic arch. One great advantage of this technique is that the ostia of the SAV remain free from a cannula, allowing the operator easier access and a faster anastomosis or reimplantation.
Novel emboli protection cannula during cardiac surgery: first animal study. [2016]Stroke after open heart surgery is a major cause of morbidity and mortality. Up to 60% of intraoperative cerebral events are caused by emboli generated by manipulations of the aorta during surgery. This is the first animal study evaluating the safety and efficacy of a novel aortic cannula designed to extract solid and gaseous emboli during cardiac surgery.
In vitro hydrodynamics of the Embol-X cannula. [2019]Prevention of intraoperative plaque dislodgement in patients with atherosclerotic ascending aorta by development of innovative aortic cannula designs gains growing interest in cardiac surgery. To increase knowledge about the hydrodynamics of the innovative Embol-X cannula, which includes an intra-aortic filter device targeting at atheromatous emboli capture, was the aim of the present study.
Echocardiographic comparison of the standard end-hole cannula, the soft-flow cannula, and the dispersion cannula during perfusion into the aortic arch. [2019]Dislodgement of aortic arch atheroma caused by a perfusion "jet" from the aortic cannula may be a major cause of atheroemboli during coronary artery surgery when using cardiopulmonary bypass (CPB). Two very different cannulas, the Soft-Flow aortic cannula and the Dispersion cannula, which have been designed to reduce exit velocity (cm/s) during perfusion, are compared with a standard steel tip cannula and to each other.
Flow characteristics of aortic cannulae. [2019]Atheroembolism from the ascending aorta is an emerging cause of noncardiac complications after open heart surgery. We designed a new arterial cannula specifically to reduce the exit force and velocity of blood flow, thereby reducing the "sandblasting" effect of the exiting blood jet. The cannula has a closed tip and an internal cone that diffuses blood flow such that it enters the aorta via multiple side holes. Fluid dynamics of the cannula were tested against five frequently used cannulae: Sarns High-Flow (3M Sarns High-Flow, Ann Arbor, MI, USA), DLP 83024 (DLP Inc., Grand Rapids, MI, USA), RMI ARS 024C (Research Medical Inc. of Research Industries Corp., Midvale, UT, USA), Bard 1966 (C.R. Bard Inc., Haverhill, MA, USA), and Argyle THI (Sherwood Medical Co. Sub American Home Products Corp., St. Louis, MO, USA). All cannulae had an 8.0-mm external diameter. The new cannula demonstrated a similar pressure drop and internal tip diameter as the others. The exit force (newtons) of the Soft Flow cannula was significantly less than the Sarns High-Flow (p
A novel filter-based distal embolic protection device for percutaneous intervention of saphenous vein graft lesions: results of the AMEthyst randomized controlled trial. [2014]We sought to evaluate the relative safety and efficacy of the novel Interceptor PLUS Coronary Filter System (Medtronic Vascular, Santa Rosa, California) compared with approved embolic-protection devices (e.g., GuardWire, Medtronic Vascular/FilterWire EZ, Boston Scientific, Natick, Massachusetts) during percutaneous coronary intervention (PCI) of degenerative saphenous vein grafts (SVG).
Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation. [2022]Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) is positioned within the ascending aorta to capture such debris.
Neurological outcomes of transcatheter aortic valve implantation with or without cerebral embolic protection devices: A meta-analysis. [2022]Cerebral embolic protection devices (CEPDs) are designed to prevent embolization of debris during transcatheter aortic valve implantation (TAVI). Current evidence from randomized clinical trials (RCTs) and observational studies is controversial.
Use of a Dual-Filter Cerebral Embolic Protection Device in Thoracic Endovascular Aortic Repair. [2020]The risk of periprocedural stroke after thoracic endovascular aortic repair (TEVAR) ranges from 3% to 8%. Although cerebral embolic protection devices (CEPD) are widely utilized in transcatheter aortic valve replacement, there are currently no Food and Drug Administration approved CEPDs for use in TEVAR. We report our initial experience with the off-label use of a dual-filter CEPD in patients undergoing TEVAR.
TriGuard Embolic Protection Device in percutaneous cardiac interventions with intracavitary cardiac thrombosis: A case series. [2023]Embolic cerebral protection devices are not routinely used in clinical practice during electrophysiological interventions. We report a case series of patients with intracardiac thrombosis undergoing a percutaneous left atrial appendage (LAA) closure and a ventricular tachycardia (VT) catheter ablation supported by TriGuard 3 Cerebral Embolic Protection Device.