Synchronized Cardiac Assist for Cardiogenic Shock

NCT ID: NCT02697006

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-02-16

Brief 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.

Conditions

Shock, Cardiogenic; High Risk Percutaneous Coronary Interventions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

i-cor Synchronized Cardiac Assist Device

The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

Xenios AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Liebetrau, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany

Locations

Kerckhoff Klinik

Bad Nauheim, Hesse, Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Protocol 1.1 Version 1.0

Identifier Type: -

Identifier Source: org_study_id