Cardiac Assist for Cardiogenic Shock and High Risk PCI - The Synchritude Registry - Synchritude Registry

Xenios AG0 个研究点目标入组 101 人开始时间: 2022年7月26日最近更新: 2024年8月19日

适应症

试验速览

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•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

•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

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