CARDSUP - SWISS Circulatory Support Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Primary outcome measures
- Number of deceased participants at 1 month after cardiogenic shock [Time frame: 30 days]
Secondary outcome measures (9)
- Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants [Time frame: 6 months]
- Statistical and medical analysis of vascular complications (VARC) reported by participants [Time frame: 6 months]
- Statistical and medical analysis of vascular surgery needed by participants [Time frame: 6 months]
- Statistical and medical analysis of bleeding complications (minor, major) reported by participants [Time frame: 6 months]
- Implantation time of MCS-device [Time frame: 6 months]
- Support time under MCS [Time frame: 6 months]
- Analysis of New York Heart Association (NYHA) Classification for participants [Time frame: 6 months]
- Modified rankin scale [Time frame: 6 months]
- Number of deceased participants at 6 month after cardiogenic shock [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 5 centers
- Universitätsspital Basel — Basel
- Insel Gruppe AG, Inselspital Bern — Bern
- Luzerner Kantonsspital — Lucerne
- Kantonsspital Winterthur — Winterthur
- Stadtspital Treimli — Zurich
Identifiers
NCT: NCT04117230 · 4075