Clinical trial NCT02697006: Synchronized Cardiac Assist for Cardiogenic Shock
Official title: Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Cardiogenic
High Risk Percutaneous Coronary Interventions
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2016-03-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiogenic shock or in high risk percutaneous intervention procedures in the cardiac catheterization lab

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.


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.

Primary outcomes:
measure: Number of Participants With Device and Procedure Related Serious Adverse Events
timeFrame: 30 days
measure: Number of Participants Treated With Technical Success of the Device
timeFrame: 24 hours
measure: Number of Participants With Device Performance Success
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
state: Hesse
Study officials:
affiliation: Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany
name: Christoph Liebetrau, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: