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Device

Embolic Protection Device for Heart Valve Surgery

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-randomization

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Number of patients who experience of death and delirium

Secondary outcome measures

All-cause mortality

Brief Visuospatial Memory Test - Revised (visual learning & memory and constructional praxis)

Days Alive out of Hospital

+18 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,851,282 Total Patients Enrolled

4 Trials studying Ischemic Stroke

5,817 Patients Enrolled for Ischemic Stroke

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

524,784 Total Patients Enrolled

3 Trials studying Ischemic Stroke

1,410 Patients Enrolled for Ischemic Stroke

Annetine C. Gelijns, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

401 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this experiment?

"Affirmative. According to clinicaltrials.gov, this research is currently in the process of procuring participants and was initially published on September 1st 2023 before being edited most recently on 19th September 2023. This trial seeks 842 individuals from 18 distinct sites across America."

Answered by AI

What is the overall aim of this clinical trial?

"The primary metric that will be monitored within 3 days of randomization is patient mortality and delirium rates. Secondary outcomes encompass the number of patients with disabling clinical stroke, neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS) scores ranging from 0 to 42 where higher values represent more impairment; as well as the amount of participants exhibiting a Modified Rankin Scale score ≥2 determined at 90-days post-randomization which ranges between 0 - 6 signifying no symptoms up to death respectively."

Answered by AI

At what medical facilities is this investigation being conducted?

"This clinical trial is being administered by Keck Hospital of the University of Southern California in Los Angeles, Indiana Ohio Heart in Thousand Oaks, Georgia and Emory University located in Atlanta. Moreover, 18 other sites are included as part of this medical study."

Answered by AI

Are there still vacancies in this research protocol for participants?

"Affirmative. According to the information accessible on clinicaltrials.gov, this medical trial is presently enrolling participants with 842 openings across 18 different sites; its initial posting was on September 1st 2023 and it has seen an update as recently as 19th of same month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CTSN Embolic Protection Trial

Annetine Gelijns 2023. "CTSN Embolic Protection Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027788.

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