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CTSN Embolic Protection Trial

NCT06027788 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 842

Last updated 2025-07-20

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

CardioGard Embolic Protection Cannula

The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.

DEVICE

Standard Aortic Cannula

An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.

Sponsors & Collaborators

Principal Investigators

  • Annetine C. Gelijns, PhD · Icahn School of Medicine at Mount Sinai

  • Steve Messe, MD · University of Pennsylvania

  • Alexander Iribarne, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027788 on ClinicalTrials.gov