Synchronized Cardiac Assist for Cardiogenic Shock

Xenios

Status: Completed

Conditions: High Risk Percutaneous Coronary Interventions; Shock, Cardiogenic

Treatments: Device: i-cor Synchronized Cardiac Assist Device

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02697006

Protocol 1.1 Version 1.0

Details and patient eligibility

About

The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.

Enrollment: 47 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients in cardiogenic shock in the setting of acute myocardial infarction

or

Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.

Cardiogenic shock is defined as

• Systolic blood pressure < 90 mmHg for at least 30 min or
• Inotropes are needed to maintain blood pressure > 90 mmHg or
• Clinical signs of heart insufficiency with pulmonary congestion or
• Signs of end organ hypoperfusion with at least one of the following criteria:
• Altered mental status
• cold, damp skin or extremities
• oliguria (≤ 30 mL/h)
• serum lactate > 2.0 mmol/L

Written consent of the patient or the legal caregiver

Exclusion criteria

• Age > 85 years
• Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 10 min
• Coma with fixed pupils not induced by drugs;
• Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
• Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
• Fever (Body temperature > 38.0 °C) or other evidence of sepsis
• Onset of cardiogenic shock > 6 h before enrollment;
• Lactate > 22 mmol/L;
• Massive pulmonary embolism;
• Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
• Previous known aortic regurgitation greater than grade II
• Contra-indications for anticoagulation
• Severe hemolysis of any cause
• Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.

Trial design