CTSN Embolic Protection Trial

Conditions

• Acute Kidney Injury
• Coronary Artery Disease
• Delirium
• Heart Valve Disease
• Ischemic Stroke

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CardioGard Embolic Protection Cannula — DEVICE
  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.
• Standard Aortic Cannula — DEVICE
  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.

Study Details

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

Key Dates

Start date

Sep 18, 2023

Status verified

May 2026

Primary completion

Apr 1, 2027

Completion

Apr 1, 2027

Study Design

Enrollment

842 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: CardioGard Embolic Protection Cannula
  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).
• Placebo Comparator: Standard Aortic Cannula
  In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice

Primary Outcome Measure

Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI) [ Time Frame: within 3 days post-randomization ]

Central Contacts

• Claudia Merlin
  917-494-2387
  [email protected]

Locations (24)

Find similar trials in North Little Rock, AR

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