Synchronized Cardiac Assist for Cardiogenic Shock

Completed

• Conditions: Shock, Cardiogenic; High Risk Percutaneous Coronary Interventions

• Registration Number: NCT02697006
• Lead Sponsor: Xenios AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Primary Completion: 2018-04-30
• Study Completion: 2019-02-16
• Status Verified: 2020-09
• Results First Submitted: 2021-03-17
• Results First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Results First Posted: 2022-09-16
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Device and Procedure Related Serious Adverse Events	30 days	Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.
Number of Participants Treated With Technical Success of the Device	24 hours	Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).
Number of Participants With Device Performance Success	7 days	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.

Trial Locations

Locations (1)

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Hesse, Germany