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Device

Embolic Protection Device for Heart Valve Surgery (EMPRO Trial)

N/A

Recruiting

Led By Annetine C. Gelijns, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 60 years

No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 7 days prior to randomization

Must not have

Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair

Active endocarditis at time of randomization with vegetation criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months post-randomization

Summary

This trial tests a device to help protect high-risk heart valve surgery patients from stroke & other complications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for this device trial, potential risks may include stroke, delirium, and acute kidney injury due to embolism (blockage) caused by debris dislodged during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I have no significant neurological issues as per recent tests.

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I am scheduled for aortic valve replacement surgery, possibly with additional heart or aorta procedures.

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I am scheduled for a new or repeat mitral valve replacement, with or without bypass surgery.

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I am scheduled for a first-time or repeat mitral valve repair and coronary artery bypass surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I currently have an active heart infection with signs of vegetation.

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I have not experienced severe heart failure or needed strong heart medication through an IV before joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)

Number of patients who experience of death and delirium

Secondary study objectives

All-cause mortality

Days Alive out of Hospital

Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)

+15 more

Trial Design

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

0 / 8Eligibility criteria met