Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 1500
- Locations
- 5
- Primary Endpoint
- Number of deceased participants at 1 month after cardiogenic shock
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
Detailed Description
This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative). The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices.
- •Signed informed consent by patient or relative or waived consent by EC
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of deceased participants at 1 month after cardiogenic shock
Time Frame: 30 days
All-cause mortality at 30 days
Secondary Outcomes
- Support time under MCS(6 months)
- Statistical and medical analysis of vascular complications (VARC) reported by participants(6 months)
- Statistical and medical analysis of vascular surgery needed by participants(6 months)
- Analysis of New York Heart Association (NYHA) Classification for participants(6 months)
- Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants(6 months)
- Implantation time of MCS-device(6 months)
- Modified rankin scale(6 months)
- Statistical and medical analysis of bleeding complications (minor, major) reported by participants(6 months)
- Number of deceased participants at 6 month after cardiogenic shock(6 months)