Registry for patients receiving ECMO or Impella devices
Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
This study is gathering information from patients who are receiving ECMO or Impella devices to see how well these treatments work for heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 5 sites (Basel and 4 other locations) |
| Trial ID | NCT04117230 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect baseline clinical and procedural data from patients undergoing ECMO or Impella implantation across multiple sites. It includes all eligible patients who consent to participate, allowing for a comprehensive assessment of clinical outcomes. The data collected will help evaluate the effectiveness and safety of these circulatory support devices in treating cardiogenic shock. The registry operates independently of the treating physician's decisions regarding device use.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require implantation of a peripheral cannulated VA-ECMO or Impella device.
Not a fit: Patients who do not meet the medical criteria for ECMO or Impella implantation will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of treatment outcomes and improve care for patients with cardiogenic shock.
How similar studies have performed: Other studies have shown success with similar observational registries, indicating the potential for valuable insights into patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel and 4 other locations
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
- Insel Gruppe AG, Inselspital Bern — Bern, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
- Stadtspital Treimli — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Lukas C Hunziker Munsch, Prof MD
- Email: lukas.hunziker@insel.ch
- Phone: 0041316322111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.