DRKS00028527
Completed
N/A
Cardiac Assist for Cardiogenic Shock and High Risk PCI - The Synchritude Registry - Synchritude Registry
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- R57.0
- Sponsor
- Xenios AG
- Enrollment
- 101
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients treated with the i\-COR® system had one of the following two medical problems:
- •\- Patients in cardiogenic shock
- •\- Patients undergoing high risk coronary revascularization procedures (e.g., multi\-vessel disease, unprotected left main, or last patent conduit interventions) in the catheterization lab
- •\- Patient or legal caregiver has provided written consent prior to data collection.
- •Cardiogenic shock was 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 cardiac insufficiency with pulmonary congestion or
- •\- Signs of end organ hypoperfusion with at least one of the following criteria:
- •\- Altered mental status
Exclusion Criteria
- •Candidates are ineligible for enrollment in the study if any of the following conditions were identified at the screening or baseline visits:
- •\- Coma with fixed pupils not induced by drugs
- •\- Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
- •\- 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
- •\- Use of radio frequency surgical instruments
- •\- Use of a reservoir was prohibited
Outcomes
Primary Outcomes
Not specified
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