Synchronized Cardiac Assist for Cardiogenic Shock

Shock, Cardiogenic Clinical Trial

Official title:

Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697006
• Other study ID #: Protocol 1.1 Version 1.0
• Status: Completed
• Start date: January 2016
• Est. completion date: February 16, 2019

Study information

• Verified date: September 2020
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 16, 2019
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Risk Percutaneous Coronary Interventions
• Shock
• Shock, Cardiogenic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik	Bad Nauheim	Hesse

Sponsors (2)

Lead Sponsor	Collaborator
Xenios AG	MAXIS Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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