Synchronized Cardiac Assist for Cardiogenic Shock

X

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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