N/A
N=47
Synchronized Cardiac Assist for Cardiogenic Shock
Shock, Cardiogenic · High Risk Percutaneous Coronary Interventions
Bottom Line
View on ClinicalTrials.gov: NCT02697006 ↗Enrolled (actual)
47
Serious AEs
31.9%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants With Device and Procedure Related Serious Adverse Events — 11; 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- i-cor Synchronized Cardiac Assist Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xenios AG
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Device and Procedure Related Serious Adverse Events |
11; 5 | — |
| PRIMARY Number of Participants Treated With Technical Success of the Device |
34; 13 | — |
| PRIMARY Number of Participants With Device Performance Success |
34; 13 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT02697006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.