Synchronized Cardiac Assist for Cardiogenic Shock

NCT02697006 | Completed Results DMC

• 1 other identifier: Protocol 1.1 Version 1.0
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

i-cor Synchronized Cardiac Assist Device 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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients in cardiogenic shock in the setting of acute myocardial infarction
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xenios AG: lead
• Avania: collaborator

Study Sites (1)

Kerckhoff Klinik

Bad Nauheim, Hesse, 61231, Germany

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Limitations and Caveats

The low resistance puls kit oxygenator was not available at the inception of, nor the duration of the study, and therefore, efforts to demonstrate the physiological effect of ECG-synchronized, primarily diastolic assist cannot be determined by this study.

Results Point of Contact

• Title: Dr. Anja Derlet-Savoia
• Organization: Fresenius MCD

Anja.Derlet@fmc-ag.com

+49 6172 608 2801

Study Officials

• Christoph Liebetrau, Dr. med.

  Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 2, 2016
• Study Start: January 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: February 16, 2019
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)