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Clinical Trials/DRKS00028527
DRKS00028527
Completed
N/A

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

Xenios AG0 sites101 target enrollmentJuly 26, 2022

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.

Registry
who.int
Start Date
July 26, 2022
End Date
October 30, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Xenios AG

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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