CARDSUP - SWISS Circulatory Support Registry
CARDSUP
Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
1 other identifier
observational
1,500
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2019
CompletedFirst Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2034
December 6, 2024
December 1, 2024
15.1 years
October 3, 2019
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of deceased participants at 1 month after cardiogenic shock
All-cause mortality at 30 days
30 days
Secondary Outcomes (9)
Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants
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
Statistical and medical analysis of bleeding complications (minor, major) reported by participants
6 months
Implantation time of MCS-device
6 months
- +4 more secondary outcomes
Eligibility Criteria
In an all-comers design, every patient receiving an MCS will be included.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Universitätsspital Basel
Basel, 4053, Switzerland
Insel Gruppe AG, Inselspital Bern
Bern, 3010, Switzerland
Luzerner Kantonsspital
Lucerne, 3600, Switzerland
Kantonsspital Winterthur
Winterthur, 8400, Switzerland
Stadtspital Treimli
Zurich, 8063, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lukas C Hunziker Munsch, Prof MD
University of Bern
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 7, 2019
Study Start
August 9, 2019
Primary Completion (Estimated)
August 31, 2034
Study Completion (Estimated)
August 31, 2034
Last Updated
December 6, 2024
Record last verified: 2024-12