Synchronized Cardiac Assist for Cardiogenic Shock

• Status: Completed
• Trial end date: 2019-02-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xenios AG
• Collaborator: MAXIS Medical

Criteria

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.