High Risk Percutaneous Coronary Interventions, Shock, Cardiogenic
Conditions
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.
Interventions
DEVICEi-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.
Sponsors
Avania
Xenios AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-Risk PCI Group Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab | 34 |
| Cardiogenic Shock Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock) | 13 |
| Total | 47 |
Baseline characteristics
| Characteristic | Cardiogenic Shock | Total | High-Risk PCI Group |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 11.7 | 70.3 years STANDARD_DEVIATION 11.2 | 71.3 years STANDARD_DEVIATION 10.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 13 participants | 47 participants | 34 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 40 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 34 | 5 / 13 |
| other Total, other adverse events | 0 / 34 | 0 / 13 |
| serious Total, serious adverse events | 10 / 34 | 5 / 13 |
Outcome results
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).
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Risk PCI Group | Number of Participants Treated With Technical Success of the Device | 34 Participants |
| Cardiogenic Shock | Number of Participants Treated With Technical Success of the Device | 13 Participants |
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Risk PCI Group | Number of Participants With Device and Procedure Related Serious Adverse Events | 11 Participants |
| Cardiogenic Shock | Number of Participants With Device and Procedure Related Serious Adverse Events | 5 Participants |
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.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Risk PCI Group | Number of Participants With Device Performance Success | 34 Participants |
| Cardiogenic Shock | Number of Participants With Device Performance Success | 13 Participants |