CTSN Embolic Protection Trial (EMPRO)

Mount Sinai Health System

Status: Enrolling

Conditions: Coronary Artery Disease; Ischemic Stroke; Delirium; Acute Kidney Injury; Heart Valve Disease

Treatments: Device: CardioGard Embolic Protection Cannula; Device: Standard Aortic Cannula

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06027788

5U01HL088942-16 (U.S. NIH Grant/Contract)

STUDY-23-00417

Details and patient eligibility

About

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

Full description

This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure.

RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned.

STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity.

SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies

The aims of this ancillary sub-study include:

1. To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery.
2. To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery.

Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months.

All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.

Enrollment: 842 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 60 years

• Planned de novo or redo:

  • Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
  • Mitral valve replacement (MVR) ± CABG
  • Mitral Valve Repair + CABG,
  • Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure.

• No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization

• Ability to provide informed consent and comply with the protocol Exclusion Criteria

Exclusion criteria

• History of clinical stroke within 3 months prior to randomization
• Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
• Coronary catheterization within 3 days of the planned procedure
• Active endocarditis at time of randomization with vegetation criteria
• Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
• Participation in an interventional (drug or device) trial
• Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
• Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
• Planned concomitant carotid endarterectomy during index surgical procedure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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842 participants in 2 patient groups, including a placebo group

CardioGard Embolic Protection Cannula

Active Comparator group

Description:

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).

Treatment:

Device: CardioGard Embolic Protection Cannula

Standard Aortic Cannula

Placebo Comparator group

Description:

In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice

Treatment:

Device: Standard Aortic Cannula