Clinical trial NCT04117230: CARDSUP - SWISS Circulatory Support Registry
Official title: Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In an all-comers design, every patient receiving an MCS will be included.

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.

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:

* None

Primary outcomes:
measure: Number of deceased participants at 1 month after cardiogenic shock
timeFrame: 30 days
Secondary outcomes:
measure: Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants
timeFrame: 6 months
measure: Statistical and medical analysis of vascular complications (VARC) reported by participants
timeFrame: 6 months
measure: Statistical and medical analysis of vascular surgery needed by participants
timeFrame: 6 months
measure: Statistical and medical analysis of bleeding complications (minor, major) reported by participants
timeFrame: 6 months
measure: Implantation time of MCS-device
timeFrame: 6 months
measure: Support time under MCS
timeFrame: 6 months
measure: Analysis of New York Heart Association (NYHA) Classification for participants
timeFrame: 6 months
measure: Modified rankin scale
timeFrame: 6 months
measure: Number of deceased participants at 6 month after cardiogenic shock
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Insel Gruppe AG, Inselspital Bern
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich
country: Switzerland
facility: Stadtspital Treimli
Study officials:
affiliation: University of Bern
name: Lukas C Hunziker Munsch, Prof MD
role: STUDY_CHAIR
References: