Synchronized Cardiac Assist for Cardiogenic Shock

Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial

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.

Study Overview

• Status: Completed
• Conditions: Shock, Cardiogenic; High Risk Percutaneous Coronary Interventions
• Intervention / Treatment: Device: i-cor Synchronized Cardiac Assist Device

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Bad Nauheim, Hesse, Germany, 61231
      • Kerckhoff Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiogenic shock or in high risk percutaneous intervention procedures in the cardiac catheterization lab

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device and Procedure Related Serious Adverse Events	Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.	30 days
Number of Participants Treated With Technical Success of the Device	Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).	24 hours
Number of Participants With Device Performance Success	Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.	7 days

Collaborators and Investigators

• Sponsor: Xenios AG
• Collaborators: MAXIS Medical
• Investigators: Principal Investigator: Christoph Liebetrau, Dr. med., Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): February 16, 2019

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: Protocol 1.1 Version 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No