DRKS00028527CompletedNot Applicable
Cardiac Assist for Cardiogenic Shock and High Risk PCI - The Synchritude Registry - Synchritude Registry
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Xenios AG
- Enrollment
- 101
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
- •- cold, damp skin or extremities
- •- oliguria (= 30 mL/h)
- •- serum lactate > 2.0 mmol/L
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
Investigators
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