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

• Conditions: Angina pectoris; Subsequent myocardial infarction; R57.0; Atherosclerotic heart disease; I22; I23; I25.1; Cardiogenic shock; I20; Certain current complications following acute myocardial infarction

• Registration Number: DRKS00028527
• Lead Sponsor: Xenios AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-10-30
• Study Start: 2022-07-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Patients treated with the i-COR® system had one of the following two medical problems:
- Patients in cardiogenic shock
or
- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The purpose of this study is to perform post-market<br>surveillance and evaluate prospectively the performance of the i-COR® SYNCHRONIZED CARDIAC ASSIST device in patients with cardiogenic shock or in patients undergoing high risk percutaneous intervention procedures in the catheterization lab.

Secondary Outcome Measures

Name	Time	Method
no secondary endpoint